Labor management devices for pelvic floor support

ABSTRACT

The present disclosure provides devices for decreasing the incidence of Cesarean childbirth by managing the labor process. In one aspect, a tactile feedback device is positioned adjacent the perianal tissues. A perianal support device includes a perianal support member having a pressure surface configured for engagement with tissue adjacent an anal orifice and a pressure detecting system associated with the perianal support member to detect pressure indicative of pressure on the perianal tissue of a patient.

PRIORITY

This application is a continuation of U.S. patent application Ser. No.14/543,251, filed Nov. 17, 2014, which is a continuation of U.S. patentapplication Ser. No. 14/195,070, filed Mar. 3, 2014 (now U.S. Pat. No.8,888,719), which is a continuation of U.S. patent application Ser. No.13/833,189, filed Mar. 15, 2013 (now U.S. Pat. No. 8,684,954), whichclaims priority to and the benefit of the filing date of U.S. PatentApplication No. 61/782,814 filed Mar. 14, 2013, titled Labor ManagementDevices and Methods for Decreasing the Incidence of Cesarean Childbirth,each of which is incorporated herein by reference in their entireties.

INCORPORATION BY REFERENCE

U.S. patent application Ser. No. 11/197,627 filed Aug. 5, 2005, andpublished as Patent Application Publication No. 2007/0031466, titledMethod, Apparatus and System for Preventing or Reducing the Severity ofHemorrhoids commonly assigned to the present applicant is herebyincorporated by reference in its entirety.

U.S. patent application Ser. No. 11/743,858 filed May 3, 2007, issued asU.S. Pat. No. 7,673,633 entitled Apparatus and Method of InhibitingPerianal Tissue Damage commonly assigned to the present applicant ishereby incorporated by reference in its entirety.

U.S. patent application Ser. No. 12/106,956 filed Apr. 21, 2008, andpublished as Patent Application Publication No. 2008/0202505 entitledApparatus and Method of Supporting Patient Tissue, commonly assigned tothe present applicant is hereby incorporated by reference in itsentirety.

BACKGROUND

The use of epidurals and pain relieving drugs during the labor anddelivery process can desensitize the birthing mother from experiencingthe natural body signals needed to push the baby through the birth canaland thereby ultimately delay the progression of childbirth. Oneindication of this phenomenon is that in modern times, there has been adramatic increase in the incidence of children born by Cesareanchildbirth. This form of child birth significantly increases the cost tothe healthcare system when compared to a natural vaginal delivery. Inaddition, the birthing mother needs significantly more time to recoverfrom a Cesarean operation compared to a natural vaginal child delivery.

While prior apparatus and methods like those disclosed in U.S. PatentApplication Publications 2007/0031466 and U.S. Pat. No. 7,673,633provide stable support for the soft perianal tissues near the analorifice, these can be further improved to provide additional benefitsfor labor management to decrease the incidence of Cesarean childbirth.More specifically, there are no currently available devices and methodsthat permit a healthcare provider to actively manage the labor andbirthing process to promote a higher incidence of vaginal births and, ifdesired in certain situations, manage the labor process to avoidpotential lifelong damage to the mother such as pelvic floor injuriesand anal sphincter damage.

Thus, there is a need for devices and methods permitting the managementof the child birthing process to encourage vaginal child birth to reducethe incidence of Cesarean childbirths.

SUMMARY

In one aspect, the present disclosure provides a method of decreasingthe incidence of Cesarean childbirth by managing the labor process. Inone aspect, a tactile feedback device is positioned adjacent theperianal tissues. A mother's labor is monitored for the progression ofthe baby along the birth canal. If the monitoring determines that thebirthing process is not progressing as desired, the sensation offered bythe tactile feedback device can be increased. In one aspect, the tactilefeedback device is a pressure inducing device. In one aspect, thepressure inducing device is applied to the perianal tissue with a firstpressure and then after monitoring the mother's condition, the device isrepositioned to provide a second pressure on the perianal tissues. Inone aspect, the second pressure is greater than the first pressure. In afurther aspect, the device includes a pressure indicator and the methodincludes monitoring the relative pressure applied to the perianaltissue.

In still a further feature of the present disclosure, a method isprovided that reduces the duration of second stage labor and delivery byallowing a healthcare provider to monitor and guide the labor process.The method includes applying a tactile feedback device in engagementwith the perianal tissue and monitoring the progression of labor duringthe second stage. If second stage labor deviates from a predeterminedtime and position progress estimation, the tactile feedback device isadjusted. If the mother is below the predetermined time and positionprogress estimation, in one embodiment, the amount of tactile feedbackis increased. In one feature, the tactile feedback device is a pressureinducing device and tactile feedback is increased by increasing therelative amount of pressure on the perianal tissue by increasing thepressure from a first initial engagement to a second higher pressureperianal tissue engagement. Such a method allows the healthcare providerto monitor the effectiveness of a mother's contractions via the impacton the perianal tissues while also providing both the healthcareprovider and mother with a feedback mechanism to have a reference forturning unsuccessful contractions into effective pushes that tend tomove the baby down the birth canal. In this manner, the present systemand method allow cooperation between the patient and healthcare providerto allow the labor and delivery process to be managed to more quicklyachieve a vaginal delivery and obviate the need for Cesarean sectiondelivery techniques.

In yet a further feature of the present disclosure, a method is providedto inhibit the evulsion or protrusion of soft tissue adjacent the anus.The method includes positioning a blocking element adjacent the perianaltissues. The blocking element is configured to inhibit the evulsion orprotrusion of soft tissue adjacent the anus. In one feature, theblocking element is initially spaced slightly from the perianal tissuesuch that some outward movement of the perianal tissue is permitted butupon engagement with the blocking element further outward movement bythe tissue is inhibited. This engagement can increase the tactilefeedback to the mother by providing a change in tactile sensation uponengagement with the blocking element. In an alternative feature, theblocking element is initially positioned in contact with the perianaltissue without providing significant pressure on the perianal tissuessuch that the location of the tissues are maintained but not compressedinward toward the anus of the patient. One aspect of the method allows ahealthcare provider to monitor, via the blocking element, the amount ofpressure applied to the blocking element by engagement with the blockingelement during contractions or pushes during the birthing process.

In still a further feature of the present disclosure, a method isprovided to protect a mother from pelvic floor injuries and analsphincter damage. In one aspect, the method includes applying a blockingmember adjacent the perianal tissue to inhibit evulsion or protrusion ofthe soft tissue. In one form, the blocking member is applied adjacentthe perianal tissues in an initial non-pressure inducing engagement. Theblocking member can include a pressure detection feature and thehealthcare provider can monitor the pressure detector during pushing andcontractions of the patient to evaluate the amount of pressure appliedto the perianal tissue. If the pressure is above an upper threshold, thepatient will be encouraged to reduce the extent of their efforts atpushing during contractions. However, if the pressure detectionindicates a pressure below a lower threshold, the healthcare providerwill encourage the patient to apply more downward pressure duringcontracts to more effectively push the baby down the birth canal towardthe vaginal opening. In this manner, the healthcare provider can managethe mother's labor to maintain the pressure on the perianal tissueswithin a desired range that is safe for the mother's tissue while at thesame time encouraging proficient pushing from the mother to advance thelabor and delivery process to avoid stalled delivery and encourage fetaldecent to achieve a vaginal child birth.

In still a further feature, a method is provided for managing thebirthing process. In an initial phase, it is determined whether themother has previously had a successful vaginal delivery. If yes, thenthe mother is allowed to continue with unaided labor. Even for thismother, labor is continually monitored and if the progression of laborslows, then a tactile feedback device may be applied to the perianaltissue and the method continues as set forth below. If the mother hasnot previously had a successful vaginal delivery, this could includefirst time nulliparous mothers or women attempting vaginal births afterCesarean deliveries, a tactile feedback device is applied to theperianal tissue. In one form, the tactile feedback device is applied ina pressure engagement position such that the perianal tissue isdisplaced inwardly and a first pressure is applied. In an alternativeform, the tactile feedback device is positioned adjacent the perianaltissue without pressure such that the perianal tissue is not displacedinwardly. The mother may then be allowed to continue with an aided ormanaged labor process. In a further feature, the managed labor processcontinues with a healthcare provider receiving feedback from the deviceto evaluate the effectiveness of the mother's pushing efforts duringcontractions. If the feedback device indicates pushes above a first,minimum threshold, the mother may continue her labor efforts withoutchange. If the feedback device indicates pushes below the first, minimumthreshold, the healthcare provide will instruct the patient ontechniques to channel contraction efforts into effective pushes urgingthe baby downward along the birth canal. If the patient continues tostruggle to achieve effective pushes and labor is not progressing, thenthe healthcare provider may increase the pressure applied by the tactilefeedback device on the perianal tissues to provide the mother with evengreater tactile feedback. In one aspect, if the mother receives anepidural or other pain relieving medication, then the healthcare providewould responsively increase the pressure applied by the tactile feedbackdevice on the perianal tissue in an effort to overcome the effects ofthe numbing treatment given to the mother. In still a furtheralternative aspect of actively managing the labor process, thehealthcare provider also monitors the feedback device for pressuresabove a maximum pressure indication. Such high pressures may beindicators for pelvic floor injuries and anal sphincter damage. Thus,the healthcare provider may instruct the patient to reduce the pushingeffectiveness during contractions to limit the pressure on the mother'sdelicate tissues in an effort to inhibit damage to these tissues. In analternative feature of the present method, the healthcare providermonitors pressure applied by the tactile feedback device to maintain thepressure during contractions between the first, minimum pressure and thehigher, maximum pressure to thereby balance the needs of progressinglabor while simultaneously attempting to avoid lifelong injuries to themother.

In an exemplary aspect, the present disclosure is directed to anapparatus including a perianal support member that has a pressuresurface configured for engagement with tissue adjacent an anal orifice.A pressure detecting system may be associated with the perianal supportmember to detect pressure indicative of pressure on the tissue adjacentthe anal orifice of a patient.

In an exemplary aspect, the present disclosure is directed to a methodincluding applying a perianal support device to a perianal region of apatient; monitoring pressure in the perianal region with a feedbackdevice associated with the perianal support device; advancing theperianal support device against the perianal region until the monitoredpressure meets a first pressure threshold based on the feedback device;and securing the perianal support device in a position where themonitored pressure meets the first pressure threshold. In a furtherfeature, the method includes monitoring the progression of labor andadjusting the pressure applied by the perianal support device inresponse to changes in the progression of labor, including failure ofthe baby to progress within the birth canal or failure of the mother'spushes to generate a sufficient change in pressure indicated by thepressure monitor. In one aspect, the pressure applied to the perianaltissue is increased if the progression of labor in slowed below apredetermined threshold allowing a healthcare provider to manage theprogression of labor.

In an aspect, the method further includes utilizing the feedback deviceto monitor sensed pressure changes associated with contractions andalerting a user to the pressure changes. In some aspects, alerting auser includes one of activating an audible alert, activating a visualalert, and activating a material change. In some aspects, activating avisual alert includes turning a light on, off, or changing its color.

In an aspect, the method further includes alerting a user when themonitored pressure exceeds a second pressure threshold higher than thefirst pressure threshold.

In an aspect, the pressure detecting system comprises a strain gaugedisposed on a wall portion of the perianal support member. In an aspect,the pressure detecting system comprises: a pressure detecting elementconfigured to detect pressure applied on the tissue by the perianalsupport member; and a user interface configured to display informationrelating to the pressure detected by the pressure detecting element. Inan aspect, the user interface is configured to wirelessly communicatewith the pressure detecting element. In an aspect, the pressuredetecting system comprises a compliant pad on a pressure surface of theperianal support member. In an aspect, wherein the compliant pad isconfigured to change appearance when pressure exceeds a thresholdpressure. In an aspect, the perianal support member is at leastpartially transparent.

In a further aspect, the pressure detecting system comprises: a pressuredetector; and a light associated with the pressure detector andconfigured to turn on when the pressure detector detects application ofa therapeutic pressure on the perianal tissue. In an aspect, thepressure detector comprises a pressure switch. In an aspect, thepressure switch is configured to complete a circuit when a therapeuticpressure is applied to the perianal tissue. In an aspect, the pressuredetecting system comprises: a transmitter carried on the perianalsupport member; and a receiver spaced apart from the perianal supportmember configured to receive signals from the transmitter indicative ofpressure applied by the perianal support member on the perianal tissue.In an aspect, the pressure detecting system comprises a securing memberextending from the perianal support member, the securing member beingconfigured to convey information indicative of pressure applied on theperianal tissue by the perianal support member. In an aspect, thesecuring member comprises an element configured to change appearancewhen pressure changes. In an aspect, the securing member is associatedwith a visual indicator such as an LED indicator. In an aspect, thesecuring member comprises an elastically stretchable portion and atleast one stretch inhibitor configured to inhibit stretch whenstretching is sufficient to apply a therapeutic pressure on the perianaltissue. In an aspect, the at least one stretch inhibitor is asubstantially inelastic fiber. In an aspect, the at least one stretchinhibitor is a substantially inelastic strap. In an aspect, the securingmember comprises a geometric figure that takes shape when stretching issufficient to apply a therapeutic pressure on the perianal tissue. In anaspect, the securing member comprises a strain gauge configured tomeasure strain as an indicator of a therapeutic pressure on the perianaltissue.

In yet another aspect, the apparatus includes a device adjustmentelement graspable by the patient when the perianal support member isengaged with the tissue. In an aspect, the device adjustment elementcomprises handle portions. In an aspect, the device adjustment elementcomprises: an adjustment strap extending from the perianal supportmember; and an anchor pad comprising a guide configured to guidemovement of the adjustment strap. In an aspect, the apparatus includes acompliant pad, the pressure detecting system being disposed between thecomplaint pad and the perianal support member. In an aspect, theapparatus includes a compliant pad having a pocket formed therein, thepressure detecting system being disposed within the pocket. In anaspect, the perianal support member includes a cooling applicatorconfigured to apply therapeutic cooling to the perianal tissue. In anaspect, the cooling applicator comprises a receptacle for a coolingmaterial. In an aspect, the perianal support member is a thermalconductor. In an aspect, the cooling applicator is shaped to fit flushwith the perianal support member. In an aspect, the pressure detectingsystem is configured to count contractions during child delivery.

In an exemplary aspect, the present disclosure is directed to anapparatus including a perianal support member having a pressure surfaceconfigured for engagement with tissue adjacent an anal orifice. Acooling applicator is configured to apply therapeutic cooling to theperianal tissue.

In an exemplary aspect, the cooling applicator comprises an ice pack. Inan aspect, the cooling applicator comprises a receptacle for a coolingmaterial. In an aspect, the perianal support device is a thermalconductor. In an aspect, the cooling applicator is shaped to fit flushwith the perianal support member. In an aspect, the apparatus includes apressure detecting system associated with the perianal support member todetect pressure indicative of pressure on the tissue adjacent the analorifice of a patient. In an aspect, the pressure detecting systemcomprises a strain gauge disposed on a wall portion of the perianalsupport member. In an aspect, the pressure detecting system comprises: apressure detecting element configured to detect pressure applied on thetissue by the perianal support member; and a user interface configuredto display information relating to the pressure detected by the pressuredetecting element. In an aspect, the user interface is configured towirelessly communicate with the pressure detecting element.

In an aspect, the pressure detecting system comprises a securing memberextending from the perianal support member, the securing member beingconfigured to convey information indicative of pressure applied on theperianal tissue by the perianal support member. In an aspect, a deviceadjustment element graspable by the patient when the perianal supportmember is engaged with the tissue. In an aspect, the device adjustmentelement comprises handle portions.

In an exemplary aspect, the present disclosure is directed to anapparatus, including a perianal support member including a pressuresurface configured for engagement with tissue adjacent an anal orifice.A device adjustment element is graspable by the patient when theperianal support member is engaged with the tissue.

In an aspect, the device adjustment element comprises handle portions.In an aspect, the device adjustment element comprises: an adjustmentstrap extending from the perianal support member; and an anchor padcomprising a guide configured to guide movement of the adjustment strap.In an aspect, the perianal support member includes a cooling applicatorconfigured to apply therapeutic cooling to the perianal tissue. In anaspect, the cooling applicator comprises an ice pack. In an aspect, thecooling applicator comprises a receptacle for a cooling material. In anaspect, the perianal support device is a thermal conductor. In anaspect, the cooling applicator is shaped to fit flush with the perianalsupport member. In an aspect, the apparatus includes a pressuredetecting system associated with the perianal support member to detectpressure indicative of pressure on the tissue adjacent the anal orificeof a patient. In an aspect, the pressure detecting system comprises astrain gauge disposed on a wall portion of the perianal support member.In an aspect, the pressure detecting system comprises: a pressuredetecting element configured to detect pressure applied on the tissue bythe perianal support member; and a user interface configured to displayinformation relating to the pressure detected by the pressure detectingelement. In an aspect, the user interface is configured to wirelesslycommunicate with the pressure detecting element. In an aspect, thepressure detecting system comprises a securing member extending from theperianal support member, the securing member being configured to conveyinformation indicative of pressure applied on the perianal tissue by theperianal support member.

In an exemplary aspect, the present disclosure is directed to a method,comprising: providing a support member having a pressure surfaceconfigured for engaging the perianal area of a patient and an elongatedcompression element; positioning the pressure surface proximate theperianal area of a patient and the compression member extendingoutwardly beyond the crown of the buttocks; and detecting the pressureon the perianal area of the patient applied by the pressure surfaceagainst the perianal area of the patient.

In an aspect, detecting the pressure on the perianal area comprisesdetecting the pressure with a strain gauge disposed on the compressionelement of the perianal support member. In an aspect, the methodincludes displaying information relating to the detected pressure on auser interface. In an aspect, the method includes transmitting signalsfrom the support member to the user interface. In an aspect, the methodincludes alerting a healthcare provider when the detected pressuredetects application of a therapeutic pressure on the perianal tissue. Inan aspect, alerting a healthcare provider comprises changing the colorof a compliant pad. In an aspect, alerting a healthcare providercomprises turning on a light bulb. In an aspect, alerting a health careprovider comprises inhibiting stretch of a securing member whenstretching is sufficient to apply a therapeutic pressure on the perianaltissue. In an aspect, the method includes therapeutically cooling theperianal tissue with the support member.

In an exemplary aspect, the present disclosure is directed to a methodof inhibiting perianal tissue damage during childbirth, comprising:positioning a perianal support device in contact with at least a portionof the perianal tissue of the patient prior to delivery of a child;positioning a compression member associated with the support device toextend outwardly in the saggital plane beyond a gluteal cleft; adjustingpressure applied on the perianal tissue until a pressure detectingsystem indicates application of a therapeutic pressure by the perianalsupport device.

In an aspect, adjusting pressure applied comprises pulling a deviceadjustment element attached to the perianal support device to increasethe pressure on the perianal tissue. In an aspect, the method includesmonitoring the pressure detecting system to confirm the applied pressureis above a therapeutic pressure threshold. In an aspect, the methodincludes detecting the pressure with a strain gauge disposed on thecompression element of the perianal support member. In an aspect, thepressure detecting system displays information relating to the detectedpressure on a user interface. In an aspect, the method includestherapeutically cooling the perianal tissue with the support member.

Further aspects, forms, embodiments, objects, features, benefits, andadvantages of the present disclosure shall become apparent from thedetailed drawings and descriptions provided herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partial cross sectional top view of a perianal supportsystem applied to a patient with stylized depiction of the patientanatomy.

FIG. 2 is a partial perspective bottom view of the perianal supportsystem applied to a patient during child delivery.

FIG. 3 is a perspective view of one aspect of the perianal supportsystem according to an exemplary embodiment.

FIG. 4 is a perspective view of a portion of the perianal support systemaccording to an exemplary embodiment.

FIG. 5 is an end view of a portion of the perianal support system ofFIG. 4.

FIG. 6 is a side view of the perianal support system of FIG. 1 accordingto an exemplary embodiment.

FIG. 7 is a perspective view of a portion of another perianal supportsystem according to an exemplary embodiment.

FIG. 8 is an end view of a portion of the perianal support system ofFIG. 7.

FIG. 9 is a side view of a portion of the perianal support system ofFIG. 7.

FIG. 10 is a perspective view of a portion of another perianal supportsystem according to an exemplary embodiment.

FIG. 11 is an end view of a portion of the perianal support system ofFIG. 10.

FIG. 12 is a side view of a portion of the perianal support system ofFIG. 10.

FIG. 13 is an end view of a portion of another perianal support systemaccording to an exemplary embodiment.

FIG. 14 is a side view of a portion of the perianal support system ofFIG. 3.

FIG. 15 is a view of a portion of another perianal support systemaccording to an exemplary embodiment in an un-stretched condition.

FIG. 16 is a view of the portion of the perianal support system of FIG.15 in a stretched condition.

FIG. 17 is a view of a portion of another perianal support systemaccording to an exemplary embodiment in an un-stretched condition.

FIG. 18 is a view of the portion of the perianal support system of FIG.17 in a stretched condition.

FIG. 19 is a view of a portion of another perianal support systemaccording to an exemplary embodiment in an un-stretched condition.

FIG. 20 is a view of the portion of the perianal support system of FIG.19 in a stretched condition.

FIG. 21 is a view of a portion of another perianal support systemaccording to an exemplary embodiment in an un-stretched condition.

FIG. 22 is a side view of the portion of the perianal support system ofFIG. 21.

FIG. 23 is a view of the portion of the perianal support system of FIG.21 in a stretched condition.

FIG. 24 is a side view of the portion of the perianal support system ofFIG. 21 in a stretched condition.

FIG. 25 is a view of a portion of another perianal support systemaccording to an exemplary embodiment in an un-stretched condition.

FIG. 26 is a view of the portion of the perianal support system of FIG.26 in a stretched condition.

FIG. 27 is a view of a portion of another perianal support systemaccording to an exemplary embodiment in an un-stretched condition.

FIG. 28 is a view of the portion of the perianal support system of FIG.17 in a stretched condition.

FIG. 29 is a perspective view of one aspect of the perianal supportsystem according to an exemplary embodiment.

FIG. 30 is a partial perspective bottom view of the perianal supportsystem applied to a patient during child delivery.

FIG. 31 is a perspective view of one aspect of the perianal supportsystem according to an exemplary embodiment.

FIG. 32 is a view of a portion of another perianal support systemaccording to an exemplary embodiment.

FIG. 33 is a view of a portion of another perianal support systemaccording to an exemplary embodiment.

FIG. 34 is a view of a portion of another perianal support systemaccording to an exemplary embodiment.

FIG. 35 is a view of a portion of another perianal support systemaccording to an exemplary embodiment.

FIG. 36 is a view of a portion of another perianal support systemaccording to an exemplary embodiment.

FIG. 37 illustrates a method of managing a mother's child birthing laboraccording to an exemplary embodiment.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of the disclosure is intended. Any alterations and furthermodifications in the described devices, instruments, methods, and anyfurther application of the principles of the disclosure as describedherein are contemplated as would normally occur to one skilled in theart to which the disclosure relates. In particular, it is fullycontemplated that the features, components, and/or steps described withrespect to one embodiment may be combined with the features, components,and/or steps described with respect to other embodiments of the presentdisclosure.

The present disclosure is directed to systems, devices, and methods formanaging child birthing labor along with supporting or treating perianaltissue of a patient. These systems introduce novel elements and methodsthat may improve the reliability, the predictability, and theeffectiveness of labor along with supporting or treating the perianaltissues. In addition, some aspects of these systems include elements andmethods that may simplify proper securing and proper placement. Someembodiments provide feedback to surgeons and patients regarding pressurelevels due to device application or physiological transformations, suchas those that occur during muscle contractions during child delivery.Supporting the perianal tissue of a patient during 2^(nd) stage labormay reduce the incidence of a number of complications and conditions,including, for example, pelvic floor incompetence or dysfunction(over-stretching of pelvic floor muscles, ligaments and tendons), organprolapse results from the over stretching, incontinence secondary topressure and stretching exerted on bladder and bladder neck, overstretching due to use of forceps in delivery, perineum tears andlacerations due to over stretching, forceps use, or uncontrolledflexion/extension of the fetal head as it descends, and hemorrhoids.Still further, application of pressure in the perianal region can besensed as a tactile sensation by a patient, often even afteradministration of an epidural and provides a pushing focal point toenhance the effectiveness of contractions and pushing. This may resultin a shortening of second stage labor by enhancing the effectiveness ofcontractions in advancing the baby down the birth canal. In addition, itmay reduce the necessity of Cesarean section deliveries by encouragingand monitoring via pressure feedback the effectiveness of contractionsto generate a pushing effect on the baby moving it toward the vaginalopening. It may also cover all or most of the anal orifice and therebyprovide defecation suppression of hemorrhoid development and oradvancement of existing hemorrhoids. Some embodiments may include apost-delivery therapeutics delivery system.

In some aspects, the devices and systems disclosed herein may includevarying pressure detecting and monitoring capabilities. For simplicity,these are referred to herein as a) a static support pressure indicationcapability, b) a dynamic support pressure indication capability, and c)an extreme support pressure indication capability. The static supportpressure indication capability may include detecting and monitoringpressure ranges that provide therapeutic support and push feedback. Thedynamic support pressure indication capability may include detecting andmonitoring pressure ranges indicative of increases in pressure levelabove the static pressure that provide feedback on push effectiveness.The extreme support pressure indication capability may include detectingand monitoring pressure ranges above desired pressures and may warrantadjusting the perianal support device in order to alleviate some thepressure on the patient.

Turning now to FIG. 1-3, a perianal support system 100 according to oneexemplary embodiment disclosed herein is illustrated in association withthe perianal tissue of a patient 10. FIGS. 1 and 2 shows the perianalsupport system 100 in use on the patient 10 and FIG. 3 shows the supportsystem 100 independent of the patient 10.

In FIG. 1, the patient 10 is shown in partial cross section toillustrate a portion of the rectum 54, anal canal 36, anal orifice 38,internal venous plexus 29, pectinate line 37 (also known as the dentateline), and external venous plexus 28. The patient's buttocks 14 and 15are shown with the crown of the buttocks 16 and 17, respectively,laterally adjacent the perianal region 26. The gluteal cleft 13 (FIG. 2)is between buttocks 14 and 15. The buttocks 14 and 15 extend laterallybeyond crowns 16 and 17 toward lateral flanks 18 and 19, respectively.The crowns 16 and 17 of each buttocks 14 and 15 in essence define themidline of each leg and the lateral flanks 18 and 19 are the arealateral of the leg/buttocks midline. The lateral flanks 18 and 19 mayinclude, for example but without limitation, all or a portion of thelateral buttocks, hips, or upper thigh of the patient.

FIG. 2 illustrates the patient 10 during a child birthing process.Contractions during labor move a child 12 into the birth canal andultimately, for a vaginal delivery, through the vaginal opening 11, asshown in FIG. 2. In an alternative birthing process, labor is commencedto move the child 12, but for a variety of reasons, the delivery doesnot occur vaginally but instead caesarian delivery is performed througha surgical opening in the mother's abdomen. During the birthing process,tremendous pressure is exerted in an effort to move the child towarddelivery. At least some of this pressure is exerted against the tissuesadjacent the anal orifice 38 in the perianal region 26 (FIG. 1). Theresult of these forces is that blood vessels near the anus, such asthose in the external venous plexus 28, may bulge or rupture causinghemorrhoids or increasing their severity. Still further, other tissuesin the perianal region 26 adjacent the anus may distend outwardlyopposite arrow A1 in FIG. 1 causing lacerations such as tearing aroundthe vaginal opening 11 or fissures from the anus. In addition to theblood loss, pain, and discomfort, these lacerations can be a locationfor infections in the mother.

The systems, devices, and methods disclosed herein, including theexemplary system 100, are shaped and structured to not only support theperianal tissues (tissue forming or supporting the perianal region 26)during the birthing process without interfering with the birthing canalor vaginal opening 11, but also include features, elements, or structurethat simplify application to the patient by providing indicators thatdetect pressure or indicate when desired application pressures areachieved. Some exemplary embodiments provide feedback to surgeons andpatients regarding pressure levels due to device application orphysiological transformations, such as those that occur during musclecontractions during child delivery. Additional exemplary embodimentsprovide user adjustment systems and techniques, allowing a patient aswell as a doctor to adjust the devices for comfort and effectiveness.Accordingly, the exemplary systems, devices, and methods disclosedherein support the perianal tissue to inhibit damage to the tissue nearthe anal orifice 38, both internally and externally, to inhibit, forexample but without limitation, the formation or advancement of externalhemorrhoids, and/or to inhibit the formation or advancement oflacerations of the perianal tissues.

FIG. 3 shows the support system 100 independent of the patient. Thesupport system 100 includes a perianal support member 102 having anexternal pressure surface 104 and a pair of extending securing members106, 107 attached to and configured to assist in holding the perianalsupport member 102 in pressurized engagement with the perianal tissue inthe perianal region 26 shown in FIGS. 1 and 2. The external pressuresurface 104 extends along midline axis 108 between a posterior edge 110and the anterior edge 112 of the perianal support member.

The perianal support member 102 includes a pair of compression elements116, 124 formed as flanges. The first compression element 116 has adistal end portion 118 adjacent the pressure surface 104 and an opposingproximal end portion 120. The opposing second compression element 124has a distal end portion 126 adjacent the pressure surface 104 and anopposing proximal end portion 128. The perianal support member 102includes an outer surface 130 and an opposing inner surface 132 (FIGS. 1and 2) defining an access cavity 136.

As shown in FIGS. 1-3, the securing member 106 is attached to the firstcompression element 116 adjacent its proximal end portion 120. In asimilar manner, the second securing member 107 is attached to the secondcompression member 118 adjacent its proximal end portion 128. In theillustrated embodiment, the securing members 106, 107 are elongated,flexible strips of a material. Midline end portions 140, 142 of thesecuring members 106, 107 attach to the compression elements 116, 118 ofthe perianal support member 102 while opposing lateral ends 144, 146extend outwardly laterally from the midline or contact axis 108 of theperianal support system 100.

The first securing member 106 forms all or a part of a securingmechanism 180. In the embodiment in FIGS. 1-3, the securing mechanism180 includes the securing member 106 and an associated anchor pad 182.In this example, the securing member 106 includes a first half of areleasable fastening system on a surface 183, such as a hook and loopsystem or a releasable adhesive system. In the illustrated embodiment,the anchor pad 182 has a generally square shape that is shorter inlength and wider than elongated securing member 106. The shape of theanchor pad is shown for illustration purposes and may take any form thatis suitable for fixing to a patient or inanimate object, as well asjoining to the elongated fixation member. The anchor pad 182 includes afirst surface 184 having an adhesive surface adapted for joining to thepatient's skin or some inanimate object. The opposing surface 185includes the second half of the releasable fastening system. In asimilar manner, the securing member 107 forms all or part of a securingmechanism 186 and includes a releasable fastening system on surface 187,such as a hook and loop system or a releasable adhesive system. In thisexample, a second component of the securing mechanism 186 includes ananchor pad 188. In the illustrated embodiment, anchor pad 188 has agenerally rectangular shape that is shorter in length and wider thanelongated fixation member 107. The anchor pad 188 includes a firstsurface 189 having an adhesive surface adapted for joining to thepatient's skin or some inanimate object. The opposing surface 190includes the second half of the releasable fastening system.

In some embodiments, instead of using the hook and loop fastenerarrangement discussed above, at least a portion of a surfaces 183, 187of the securing members 106, 107 has an adhesive coating adapted forjoining to a fixed object. The securing member 106 may be fixed to theinner surface 132 of the compression element 116. Likewise, the securingmember 107 is joined to the proximal end portion 128 of the secondcompression element 124. At least a portion of a surface of the securingmember includes an adhesive coating that can fix the securing member toanother object. In one embodiment, the adhesive coating is adapted forreleasably adhering to a patient's skin. In another embodiment, theadhesive is adapted for joining to an inanimate object or to itself. Inthis manner, the securing member can fix the position of the perianalsupport member 102 relative to the operating table or other fixture nearthe patient. In some embodiments, the securing members are formed offlexible tape. Further, while they have been described separately, inone embodiment, the securing members are formed by a continuous piece ofmaterial joined in the middle to the perianal support member 102.

FIG. 2 shows exemplary flip preventer straps 191 that may extend fromsides at least partially in the direction of the axis 48 to reduce thelikelihood that the perianal support member 102 will flip when underloading or during adjustment. In some embodiments, the flip preventerstraps 191 are formed of flexible surgical tape. In other embodiments,the flip preventer straps 191 are hook and loop fastener portions thatattach to anchor pads similar to the anchor pads 188, but much smallerto comfortably adhere to the body.

The exemplary perianal support member 102 in FIGS. 1-3 is shown ingreater detail in FIGS. 4-6. In the example shown the first and secondcompression elements 116, 124 are integral with and define a portion ofthe perianal support member 102. The distal end portion 118 (FIG. 5) ofthe compression element 116 transitions into the pressure surface 104.The compression element 116 also includes an elongated, planar exteriorside wall 150 (FIG. 6) extending from the distal end 118 to the proximalend 120. The compression member 116 extends generally along axis 152which is substantially transverse to the midline axis 108 as shown inFIG. 5. As shown in the end view of FIG. 6, the compression element 116extends at an oblique angle A with respect to an axis 154. It will beunderstood that axis 154 is also representative of the saggital plane ofthe body and midline axis 108 extends generally within the sagittalplane. In a similar manner, the distal end 126 of the compressionelement 124 transitions into the pressure surface 104. The compressionelement 124 also includes an elongated, planar exterior side wall 160extending from the distal end 126 to the proximal end 128. Thecompression element 124 extends generally along an axis 162 which issubstantially transverse to the midline axis 108 as shown in FIG. 5. Theend view of FIG. 6 shows the compression element 124 extending at anoblique angle B with respect to the axis 154. It will be appreciatedthat in the illustrated embodiment, compression element 124 extends atan oblique angle A substantially equal to the oblique angle B at whichcompression element 116 extends with respect to axis 154. In someembodiments, the oblique angles A and B are each within the range ofabout 5 to 25 degrees. In other embodiments, the oblique angles A and Bare each within the range of about 10 to 20 degrees, and in yet otherembodiments, are with a range of about 15 to 20 degrees.

The perianal support member 102 of the perianal support system 100 hasan internal contact surface 170 defined along the midline 108 opposingthe external pressure surface 104. It will be understood that a healthcare provider may apply pressure to the contact surface 170 to move theperianal support member 102 into the operative position shown in FIGS. 1and 2 and/or apply additional pressure to compress at least someperianal tissue. The compression element 116 includes an interior wall151 while the compression element 124 has an opposing interior wall 161generally facing interior wall 151. The interior walls 151, 161, alongwith the internal contact surface 170 define the access cavity 136within the perianal support device 100. As shown in FIG. 6, theconfiguration of the perianal support member 102 as described aboveresults in a generally wedge shaped device. Still further, with theinclusion of the access cavity 136, the perianal support member 102 hasa substantially V-shaped configuration with the pressure surface 104defined at the apex of the V and the compression elements 116, 124forming the legs of the V.

In this exemplary embodiment, the support system 100 includes a pressuredetecting system 250. The pressure detecting system 250 may beassociated and configured with other components of the support system100, such as the perianal support member 102 or the securing members106, 107. In some embodiments, the pressure detecting system 250 isintegrally formed with components of the support system 100 discussedabove. That is, in some embodiments, the pressure detecting system 250is a part of the support system 100. In other embodiments, the pressuredetecting system 250 is associated with the support system 100 in amanner enabling the pressure detecting system 250 to monitor or detectthe pressure on the support system 100 or on the patient. The pressuredetecting system 250 may be configured and arranged to detect changes inpressure, stress, or strain, either directly or indirectly, that may beindicative of the amount of pressure being applied on the support system100 or by the support system 100 on perianal tissue of the patient 10.For example, the pressure detecting system 250 may directly measurepressure using pressure sensors, or may indirectly measure pressure bymonitoring, detecting, or responding to changes in shape, structure, orarrangement of various components or elements making up the supportsystem 100.

In the exemplary embodiment shown in FIGS. 1-6, the pressure detectingsystem 250 comprises a plurality of strain gauges 252, 254 disposed onthe perianal support member 102 and a user interface 256 (FIG. 6) incommunication with the strain gauges 252, 254. In some embodiments, thestrain gauges form a part of the perianal support member 102, while inother embodiments, they are adhered to the perianal support member 102.In the examples shown, a first strain gauge 252 is attached to the firstcompression element 116 and a second strain gauge 254 is attached to thesecond compression element 124. The strain gauges 252, 254 are arrangedto detect strain in the compression elements 116, 124 in a mannerindicative of loading applied to the external pressure surface at theanterior end 112 of the perianal support member and of loading at theposterior end of the perianal support member 104 as applied by thesecuring members 106, 107. The strain gauges 252, 254 may be any type ofstrain gauge including for example, a mechanical strain gauge, anelectrical resistance strain gauge, an optical strain gauge, or othertype of strain gauge.

FIG. 6 shows the strain gauges communicating with a user interface 256that is configured to communicate information relating to the strain onthe perianal support member 102 as detected by the strain gauges 252,254, which is representative of pressure being applied by the perianalsupport member 102 to the patient. The user interface 256 may display orotherwise convey to a health care provider or the patient detectedchanges in pressure level, may display or otherwise indicate whether thepressure is within a suitable range, or may display or otherwise provideother feedback to the health care provider or patient indicative ofpressure during the child delivery process. To do this, the userinterface 256 communicates with the strain gauges 252, 254. Depending onthe embodiment, the user interface 256 may communicate with the straingauges 252, 254 either by wired connection or by a wireless connection.In some embodiments, signals from the strain gauges are processed by aprocessing system, and the user interface may receive information fromthe processing system indicative of information obtained by the straingauges. In some embodiments, the user interface 256 is a table-topdevice that may be viewed by the health care provider or patient. Inother embodiments, the user interface is a handheld structure, such afob that may provide information to the health care provider or patient.Depending on the embodiment, the user interface may communicate detectedinformation in any manner that may be understood by the health careprovider or the patient. In one embodiment, the user interface 156displays values from the strain gauges indicative of strain. In simplerembodiments, the user interface may display a red light when the absenceof strain indicates that the perianal support system 100 is not applyinga desired pressure to the perianal support device and a green light whenthe detected strain indicates that the perianal support system 100 isapplying pressure within a desired range. Other interfaces arecontemplated. When the strain gauges 252, 254 are of the type measuringelectrical resistance though a conductor, the user interface 256 mayalso serve as a power source for the strain gauges. Other embodimentsuse strain gauges having an on-board power supply. Yet otherarrangements are contemplated.

Some embodiments have a user interface 256 in the form of a smartphoneor tablet, such as an iPhone®, an Android phone, an iPad®, or othersimilar device that is wirelessly connected with sensors 252 and 254. Inthis embodiment, the user interface 256 may operate a selectableapplication that may be downloaded to the user interface. In suchembodiments, the patient or the healthcare provider may opt to view theinformation from the pressure detecting system on her own personaldevice. In some embodiments, the user interface 256 may display a graphwith a line tracing the detected pressure as a timeline.

FIGS. 4-6 also show a migration barrier 194 that extends at leastpartially along the exterior side wall 150 of the first compressionelement 116 and at least partially along the exterior sidewall 160 ofthe second compression element 124. In some embodiments, the migrationbarrier may be formed of a soft, flexible silicon material configured toprevent the migration of fecal matter that may be expelled duringchildbirth. In this embodiment, the perianal support member may belocated over the anus so that the migration barrier 194 is disposedbetween the anus and the vaginal opening. The migration barrier 192 maypermit expelled matter to migrate only in the direction away from thevaginal opening. In the embodiment, shown, the migration barrier 194extends at an oblique angle relative to the axis 152, 162 and may form acurved arc as can be seen by the hidden lines in FIG. 5. Otherembodiments have a different angle and may be for example, purely linearor otherwise shaped.

FIG. 5 also shows an indicium 196 that helps a healthcare providerproperly locate the perianal support member 102 on the patient. In thisexample, the indicium is a target shape formed on the perianal supportmember 102. In use, the health care provider may align the target with abody reference marker, such as the anus. This may help ensure theperianal support member 102 is properly located to support or treatperianal tissue while maintaining suitable spacing from the vaginalopening. Although a target shape is shown, other embodiments have othershapes or indicia as indicators. Indicia may find particular utilitywhen using a transparent perianal support member 102. In this example,the indicium is spaced off-center from the axes 152, 162 in order toprovide a suitable position of the perianal support member 102 on thepatient.

FIGS. 7-9 show a portion of another exemplary embodiment of a perianalsupport system 300 in accordance with an exemplary aspect of the presentdisclosure. The support system 300 may include the perianal supportmember 102 and the securing members 106, 107 as described above withreference to the support system 100 in FIGS. 1-6. In this example, atleast a portion of the perianal support member 102 may be formed of amaterial enabling passage of light through the perianal support member102. In this embodiment, the light passing through the perianal supportmember 102 may be used as an indication of whether suitable pressure isbeing applied on the perianal tissue as explained below.

In this example, the support system 300 includes a pressure detectingsystem 302 that comprises a pressure detecting compliant pad 304 adheredto the perianal support member 102 across the majority of the pressuresurface 104. In some embodiments, the pressure-detecting compliant pad304 has a width the same width as the perianal support member 102, andin other embodiments, the pressure-detecting compliant pad 304 has awidth less than the width of the perianal support member 102. In theembodiment shown the pressure-detecting compliant pad 304 extends aboutthe pressure surface 104 and extends at least partially along theexterior side wall 150 of the first compression element 116 and at leastpartially along the exterior sidewall 160 of the second compressionelement 124. The pressure detecting compliant pad 304 may be disposedand arranged as an interfacing structure disposed between the pressuresurface 104 of the perianal support member and a patient's perianaltissue when the perianal support system 300 is disposed on a patient. Asillustrated, a first portion of the complaint pad 304 extends along andis adhered to distal end portion 118 of the compression element 116. Ina similar manner, a second portion extends along and is adhered todistal end portion 126 of the compression element 124. In oneembodiment, the compliant pad 304 is a sterile gauze pad. In anotherembodiment, the compliant pad 304 includes an internal cushioningstructure, such as polyurethane, silicon, rubber, foam, cotton, etc.,with a non-abrasive skin contact surface. The compliant pad 304 may beadhered to the perianal support member 102 across the majority of thepressure surface 104. In one embodiment, the compliant pad is die cutfrom 1776 and 1772 stock materials from 3M. Then bonding the resultinglaminate on to the compression surface as the 1772 material has anadhesive back. In another embodiment, compliant pad 304 is an absorbentmaterial adapted to absorb bodily fluids. It will be appreciated thatthe compliant pad 304 may make placement and maintenance of the supportdevice 300 more comfortable for the patient. In addition, the surface ofthe pad 304 is configured to frictionally engage the patient's perianaltissue to inhibit movement between the support device 300, particularlythe pressure surface 104 and the patient. In still a further aspect,compliant pad 304 includes a treating compound. The treating compound isdisposed within the pad, applied on the surface, or a combination ofboth. Treating compounds useful for combination with pad 304 include,but without limitation to other compounds, antibacterial compounds,antibiotic compounds, sclerants, antimicrobial compounds,anti-inflammatory compounds, anti-fungal agents, anti-itching agents,humicants, moisture absorbing agents, gas absorbing agents, bufferingagents for pH control, drying agents and the like and coagulants. In yeta further embodiment, pad 304 is not fixed to the perianal supportmember 102 but is instead positioned on the patient in advance ofpositioning the perianal support member 102 or is loosely held to theperianal support member 102 as it is applied to the body. In thisembodiment, perianal support member 102 maintains the position of thepad 304 relative to the patient's body and in particular the analorifice.

In one embodiment, the compliant pad 304 is a flexible fabric pressuresensor formed of an outer layer arranged to interface with and applypressure to the perianal tissue of the patient, a stretch conductivefabric, an Ex-static® fabric, a non-conductive adhesive, an energysource, a light source, and connection cables. A microcontroller maytranslate sensor values into the output values into a signal indicativeof pressure.

In an alternative embodiment, the pressure detecting compliant pad 304may be designed to change colors when pressure on the pad exceeds athreshold pressure. The threshold pressure may be preset and may beestablished to correspond with a therapeutic pressure that is consideredsuitable to support the perianal tissue of the patient during the childdelivery process. In one exemplary embodiment, the pad 304 is a Mylarbased film that contains a layer of tiny microcapsules. The applicationof force upon the pad causes the microcapsules to rupture, producing aninstantaneous and permanent high resolution “topographical” image ofpressure across the contact area. A film having such a construction ismarketed under the trade name FujiFilm Prescale®. Some compliant padembodiments include a liquid gel covering a colored backing. Underpressure, the gel displaces revealing the colored backing, andindicating to the health care provider that a pressure threshold hasbeen met. Other types of color indicators are also contemplated.

Some embodiments of the pressure detecting compliant pad are configuredto dynamically display the color from a low intensity color to a higherintensity color indicative of the amount of pressure. Such pads showinga graduated scale may also indicate when the pressure exceedstherapeutic pressure. When such instances occur, the healthcare providermay adjust the perianal support member 102 to reduce the pressure on theperianal tissue. In some embodiments, the pressure detecting compliantpad 304 operates as a pressure switch, where the pad 304 is a firstcolor when the switch is off, and where the pad changes color when theswitch is on.

Since the perianal support member 102 allows passage of at least somevisible light, a health care provider may be able to visually determinewhen a therapeutic pressure is applied on the pressure-detectingcompliant pad 304 based on the color emitted from the pressure detectingcompliant pad 304. In some aspects, the health care provider, even whenpositioned to receive a baby during delivery, can visually observe atleast some light emitted from the pressure-detecting compliant pad 304be observing through the internal contact surface 170 in the accesscavity 136 of the perianal support member 102. In some embodiments, theperianal support member 102 is formed of a clear plastic material thatenables a health care provider to directly see the pressure detectingcompliant pad 304. Some clear plastic materials may include acrylics orother types of polymer materials. Other embodiments are only partiallytransparent and may permit passage of light through the perianal supportmember 102 so that a health care provider can visually observe the colorof the pressure-detecting compliant pad. A partially transparentperianal support member may visually cover the patient tissue underpressure but may still permit the changes in color to be recognized bythe health care provider.

In some embodiments, the pressure detecting compliant pad 304 mayinclude a power source that provides power to electronics for emitting alight or for causing the pressure detecting compliant pad 304 to emitlight of a particular color. Other embodiments undergo a chemicalreaction or other transformation when the threshold pressure level isexceeded. The reaction or transformation causes the color change in thepressure detecting compliant pad 304.

FIGS. 10-12 show a portion of another exemplary embodiment of a perianalsupport system 350 in accordance with an exemplary aspect of the presentdisclosure. This exemplary embodiment includes a pressure detectingcompliant pad as discussed above, however the pad operates as a switchassociated with an LED indicator. When the desired or the therapeuticpressure is reached on the pressure detecting compliant pad, the bulbmay be turned on as an indicator to indicate to the health care providerthat the threshold therapeutic pressure has been met. The support system350 disclosed herein includes a perianal support member 352 and apressure detecting system 354. The pressure detecting system includes apressure detecting compliant pad 360 and an LED bulb 362. These arediscussed further below. The perianal support member 352 has many of thesame features and shape as the perianal support member 102 discussedabove. Therefore a description of the entire perianal support member 352will not be repeated here recognizing that the description above appliesto the perianal support member 352. However, in this embodiment, theperianal support member 352 includes a thick pressure zone 356 disposedbetween the external pressure surface 104 and the internal contactsurface 170. The thick pressure zone 356 is configured to house aportion of the pressure detecting system 354. In this embodiment, thethick pressure zone 356 has a thickness greater than the thickness ofthe LED bulb 362, and fully encompasses the LED bulb 362. Because of itsshape, the perianal support member 352 includes an external pressuresurface 104 similar to that discussed above, and the internal contactsurface 170 has a curved surface that is not concentric with theexternal pressure surface 104. In some embodiments, the internal contactsurface 170 is a planar surface extending between the first and secondcompression elements. In use, a health care provider can manuallyprovide pressure on the internal contact surface 170 to hold theperianal support member 352 in place on the patient until the first andsecond securing members are properly positioned. The thick pressure zone356 fully encompasses the LED bulb 362 and protects the LED bulb 362from damage that might otherwise occur when the health care providerapplies pressure on the internal contact surface 170.

The pressure detecting compliant pad 360 in this embodiment isresponsive to changes in pressure and may be a pressure switchresponsive at a repeatable and preset pressure. In some embodiments, apressure detecting compliant pad 360 may be formed of an outer layerarranged to interface with and apply pressure to the perianal tissue ofthe patient, a stretch conductive fabric, an Ex-static® fabric, anon-conductive adhesive, an energy source, a light source, andconnection cables. A microcontroller may translate detected pressureinto output signals indicative of the detected pressure.

The LED bulb 362 may form a part of a circuit with the pressuredetecting compliant pad 360 and may be in electrical communication withthe pressure detecting compliant pad 360. A power source (not shown) mayalso be disposed adjacent the LED bulb 362 in the thick pressure zone356 of the perianal support member 352. Although LED's are provided forthe purpose of illustration, the type of visual indicator is not limitedto LED's and other light sources or visual indicators can be utilizedwith the present disclosure.

In some embodiments, the LED bulb 362 is a multi-colored LED bulb witheach color indicative of a separate pressure threshold. In one exemplaryembodiment, no light may indicate pressure below a minimum threshold andthe LED bulb 362 may display green after exceeding a first pressurethreshold. The green zone of pressure may provide static supportpressure indication capability which may correspond to a pressure rangethat provides therapeutic support in a relatively static condition.During contractions and after exceeding a second pressure threshold, theLED may change to yellow indicating an increase in pressure. This yellowzone may provide dynamic support pressure indication capability, whichmay suggest that the patient is effectively pushing the baby toward thevaginal opening during the contraction. The yellow light is intended toprovide dynamic feedback during the dynamic stages of a contraction. Instill an alternative feature, if a third pressure threshold is exceeded,the LED may change to red to indicate an unsafe pressure range. This redzone may provide extreme support pressure indication capabilityindicating that pressure on the perianal tissue should be reduced.Therefore, this condition alerts the user to either cease the pushingcontractions or reposition or remove the perianal support device. Thefirst, second, and third pressure thresholds may be selected tocorrespond to desired therapeutic pressures. For example, the LED bulb362 may shine with a green light when the first pressure threshold isexceeded indicating that a partially effective pressure is being appliedto the perianal tissue, and may shine with a yellow light when thesecond pressure threshold is exceeded indicating that more effectivepressure is being applied to the perianal tissue.

In another embodiment, the LED bulb 362 is not embedded in a thickpressure zone, but is disposed on the perianal support member 352 in amanner that the LED bulb may be monitored by the health care provider.In this embodiment, pressure on the compliant pad 360 may switch on theLED bulb 362 which may be disposed anywhere along the perianal supportmember 352. In such embodiments, the transparency of the perianalsupport member 352 does not impact the effectiveness of the pressuredetecting system 354.

FIGS. 13 and 14 show a portion of another exemplary embodiment of aperianal support system 400 in accordance with an exemplary aspect ofthe present disclosure. This exemplary embodiment includes a perianalsupport member 402 and a pressure detecting system 404 that includes atransmitter 106 and an off-board receiver 408. In this embodiment, theperianal support member 402 is shaped in the same manner discussed abovewith reference to FIGS. 10-12 and includes a thick pressure zone 356 atthe apex between the external pressure surface 104 and the internalcontact surface 170. In this embodiment however, the pressure detectingsystem 404 includes a transmitter 406, a receiver 408, and a pressuredetecting compliant pad 410. The transmitter 406 is disposed on theperianal support member 402 in addition to or in place of the LED bulb362 shown in FIGS. 11 and 12. The transmitter 406 is in communicationwith the pressure detecting compliant pad 410 and may be configured toreceive signals indicative of pressure detected by the pressuredetecting compliant pad 410. In some embodiments, the signals may havebeen processed by a microcontroller carried on or otherwise incommunication with the pressure detecting compliant pad 410. In someembodiments, the signals may be directly transmitted signalsrepresentative of pressures detected by the pressure detecting compliantpad 410. In other embodiments where the pressure detecting compliant pad410 is a pressure switch, the signals may be an on/off signal indicativeof an open or closed circuit.

Depending on the embodiment, the transmitter 406 may communicate usingany uni-directional or bi-directional radio communication format.Different embodiments include, for example, a Wi-Fi bi-direction radiocommunication capability and a Bluetooth bi-direction radiocommunication capability that allow wireless communication following theWi-Fi Alliance standard and Bluetooth Special Interest Group standard.Of course, other wireless local area network (WLAN) standards andwireless personal area networks (WPAN) standards can be used.

The transmitter 406 transmits signals from the perianal support member402 to the off-board receiver 408. The receiver 408 may comprise anantenna, and receiver circuitry for processing the signals received fromthe transmitter 406. Depending on the embodiment, the receiver 108 mayinclude a microprocessor configured to interpret the signals and outputinformation via a user interface to a health care provider or thepatient. In one embodiment, the processor is configured to output actualpressure values acting on the pressure detecting compliant pad 410. Inother embodiments, the microprocessor is configured to outputinformation indicating to the health care provider whether more pressureor less pressure is recommended in order to reduce the incidence ofperianal tissue damage. In one embodiment, the receiver 408 isconfigured with a simple user interface that indicates whether theapplied pressure is above or below a therapeutic pressure threshold. Inthis embodiment, the user interface may be a single bulb that turns onwhen the signal from the transmitter indicates that the therapeuticpressure threshold has been reached.

Although disclosed as being used with the pressure detecting compliantpad 410, the transmitter 406 and receiver 408 may be used with anypressure sensing system disclosed herein, including the strain gauges,the visual indicator pad, the LED indicator, as well as the others. Theoff-board receiver 408 may store and record information obtained. In oneexample, the information is displayed over time.

When the receiver 408 is in the form of a smartphone or tablet, such asan iPhone®, an android phone, an iPad®, or other similar device asdiscussed above, the receiver may process and display the informationreceived from the transmitter on a screen. In some embodiments, thereceiver 408 communicates with the transmitter via blue-tooth, while inother embodiments, the communications occur over a Wi-Fi network.

As discussed above with reference to FIGS. 1-3, the perianal supportsystem 100 includes the first and second securing members 106, 107.FIGS. 15-28 show different securing members that may secure the perianalsupport member against the perianal tissue of the patient. Depending onthe embodiment, the securing members may attach to the patient, such asthe patient's flanks, or may extend between the perianal support memberand anchor pads. Other securing members extend between the perianalsupport member and the patient or inanimate objects, such as a part ofthe delivery bed. The securing members disclosed herein may beconfigured and arranged to provide an indication, such as a visualindication for example, of the load being applied on the perianal tissueby the perianal support member. In some embodiments, the securingmembers are arranged to indicate when a suitable therapeutic load isapplied to the perianal tissue based on the tension applied to thesecuring members.

FIGS. 15 and 16 shows an exemplary pressure detecting system 500comprising a securing member 502 that may be employed to secure theperianal support member 102 in place of the securing member 106 or 107discussed above. Here, the pressure detecting system 500 also includes apressure detecting portion 504. Some embodiments employ two securingmembers, and each securing member may include the same features. Inother embodiments, only one securing member forms the pressure detectingsystem 500, and the other securing member does not form the pressuredetecting system 500 as it may not provide feedback to the health careprovider or patient.

The securing member 502 may be formed of a substantially elasticallyextending or substantially non-extending strap. In this embodiment, itincludes a connection portion 506 to which a portion of a hook and loopfastener may be adhered. The hook and loop fastener may enable thesecuring member 502 to be adhered in place to a corresponding hook andloop fastener, such as an anchor pad. A health care provider can stretchthe securing member 502 to the increase or decrease the load applied onperianal tissue by the perianal support member.

The pressure detecting portion 504 in this embodiment is a tensiondetecting pad. The tension detecting pad is arranged to detect strainduring the loading process and provide information to a user indicativeof the amount of loading on the securing member 502. In one embodiment,it does this by changing colors, thereby providing a visual indicator tothe health care provider or patient of the amount of loading on thesecuring member 502. The amount of strain on the securing member 502 maybe directly correlated with the amount of pressure on the perianaltissue. In one embodiment, the pressure detecting portion 504 changescolor depending on the amount of strain or stretch. The amount ofstretch is directly correlated with the loading on the perianal supportmember, and therefore, the color displayed by the pressure detectingportion 504 is directly correlated with loading on the perianal supportmember. In one example the pressure detecting portion 504 is a neutralcolor when in an unloaded or a neutral condition, and changes to a greencolor when the tension in the securing member 502 is sufficient toprovide a desired load on the perianal tissue by the perianal supportmember. In some embodiments, the color changing abruptly occurs when astrain that applies a therapeutic pressure is reached, and in otherembodiments, the color change is graduated so that a health careprovider or the patient can determine about what loading is beingapplied at any one time. Accordingly, the securing member 502 may beapplied to a patient in an initial static support position. Colorchanges during contractions indicate higher pressures. As such, thedevice may provide positive user feedback on dynamic pressure changesindicative of the success or lack thereof of pushing associated withcontractions. It's worth noting that the perianal support system may beretained in position both during the static support phase and thedynamic support phase of the birthing process.

In some embodiments, the securing member 502 is formed of an elasticallyextending strap with elastomeric properties enabling the securing member502 to stretch from a neutral condition when no load is applied to astretched condition, when the securing member 502 is under a tensionload. In such an embodiment, the strain or the stretch under load may bemuch greater than in other embodiments where the securing member 502formed of a substantially non-elastic material. In such embodiments, thesecuring member 502 has elastic spring properties, such that the greaterthe distance of the stretch, the greater the load required. Otherembodiments have a substantially non-elastic securing member 502.Accordingly, the amount of strain is much less under load. The colorchanging indicator pad may be arranged to correspond with a particularsecuring member property type in order to provide a repeatable indicatorto the health care provider or patient. In some embodiments, thesecuring member 502 is formed of a thin-napped Lycra material.

FIG. 15 shows the securing member 502 and the pressure detecting portion504. In FIG. 15, the securing member is under a first load or is underno load. Therefore, the pressure detecting portion is a first color. InFIG. 16, the pressure detecting securing member 502 is under a second,greater load, and has introduced an increased level of strain into thesecuring member 504. As can be seen, the color is pad is also lengthenedand as a result, displays a different color. While shown as making uponly a portion of the securing member 502, in some embodiments, thepressure detecting portion 504 has the same width and/or length as thesecuring member 502 and in some embodiments, the pressure detectingportion 504 makes up the entire securing member 502.

FIGS. 17 and 18 show another embodiment of an exemplary pressuredetecting system 520 comprising a securing member 522 that may beemployed to secure the perianal support member 102 in place of thesecuring member 106 or 107 discussed above. Here, the pressure detectingsystem 520 also includes a pressure detecting portion 524 that mayprovide information to the health care provider or patient that asufficient tension is reached to apply a desired load through theperianal support member 102 onto the perianal tissue. This embodiment issimilar in many respects to the pressure detecting system 500 discussedabove. However, this embodiment includes an electrical light indicator526 in place of the color changing indicator tension detecting paddiscussed above. In this embodiment, the strain or change in length ofthe strap can be monitored and used to provide feedback to the lightindicator 526. The light indicator 526 is, in the embodiment shown, anLED bulb that is configured to emit light when powered. Leads on the LEDconnect to a power source and to a strain detector that may operate as aswitch when the strain exceeds a threshold strain. The threshold strainmay be selected to correspond to a desired pressure on the perianaltissue when the securing member 522 is angled to provide the loadingthrough the perianal support member. In one embodiment, the angle is oneshown in FIG. 1, where the securing member extends to the lateralflanks.

FIG. 17 shows the securing member 522 and the pressure detecting portion524. In FIG. 17, the securing member 522 is under a first load or isunder no load. Therefore, the pressure detecting portion 524 is off, oris not lit. In FIG. 15, the pressure detecting securing member 522 isunder a second, greater load, and has introduced a sufficient level ofstrain into the securing member 522. As can be seen, the pressuredetecting portion 524 is therefore on, powered, or lit, indicating thatthe securing member 522 is under a tension load sufficient to applysuitable tension on the perianal tissue.

FIGS. 19 and 20 show another embodiment of an exemplary pressuredetecting system 540 comprising a securing member 542 that may beemployed to secure the perianal support member 102 in place of thesecuring member 106 or 107 discussed above. Here, the pressure detectingsystem 540 also includes a pressure detecting portion 544 that mayprovide information to the health care provider or patient that asufficient tension is reached to apply a desired load through theperianal support member 102 onto the perianal tissue. In thisembodiment, the securing member 542 is an elastically extending memberthat may extend from a neutral or un-stretched condition to a stretchedcondition. In some embodiments, the securing member 542 has elasticproperties where the tension force increases non-linearly as thematerial is stretched.

The pressure detecting portion 544 in this embodiment comprises aplurality if inelastic fibers or indicators whose profiles provide anindication of tension loading on the pressure detecting system 540. Thepressure detecting portion 544 can be seen in both FIGS. 19 and 20. InFIG. 19, the inelastic fibers are curved or are not straight. This mayindicate that the tension loading on the securing member 542 is lessthan a threshold pressure, and therefore, the securing member 542 is notproviding a desired load on the perianal tissue through the perianalsupport member. FIG. 20 shows the securing member 542 stretched furtherthan in FIG. 19. As a result, the inelastic fibers have straightenedout. In this embodiment, the securing member and the pressure detectingportion 544 is designed so that the desired pressure on the perianaltissue corresponds with the straightening of the inelastic fibers.Accordingly, when the inelastic fibers are substantially straight, thepressure on the perianal tissue has reached or exceeded the desiredloading on the perianal tissue. The fiber profile in FIG. 20 correspondsto a desired pressure on the perianal tissue.

FIGS. 21-24 show yet another embodiment of an exemplary pressuredetecting system 560 comprising a securing member 562 that may beemployed to secure the perianal support member 102 in place of thesecuring member 106 or 107 discussed above. FIGS. 21 and 22 show thepressure detecting system 560 in an un-stretched state and FIGS. 23 and24 show the pressure detecting system 560 in a stretched state. FIGS. 21and 23 show a top view of the pressure detecting system 560 and FIGS. 22and 24 show side views. Here, the pressure detecting system 560 alsoincludes a pressure detecting portion 564 that may provide informationto the health care provider or patient that a sufficient tension isreached to apply a desired load through the perianal support member 102onto the perianal tissue. In this embodiment, the securing member 562 isan elastically extending member that may extend from a neutral orun-stretched condition to a stretched condition as discussed above.

The pressure detecting portion 564 is in this embodiment comprises aninelastic strap or indicator whose profile provides an indication oftension loading on the pressure detecting system 560. The pressuredetecting portion 564 can be seen best in FIGS. 21 and 23. In FIGS. 19and 20, the inelastic strap is not stretched or is not taut. This mayindicate that the tension loading on the securing member 562 is lessthan a threshold pressure, and therefore, the securing member 562 is notproviding a desired load on the perianal tissue through the perianalsupport member. FIGS. 21 and 22 show the securing member 542 stretchedfurther than in FIGS. 19 and 20. As a result, the inelastic strap hasstraightened out. In this embodiment, the securing member 562 and thepressure detecting portion 564 are designed so that the desired pressureon the perianal tissue corresponds with the straightening of theinelastic strap. Accordingly, when the inelastic strap is substantiallystraight, the pressure on the perianal tissue has reached or exceededthe desired loading on the perianal tissue.

FIGS. 25 and 26 show another embodiment of an exemplary pressuredetecting system 580 comprising a securing member 582 that may beemployed to secure the perianal support member 102 in place of thesecuring member 106 or 107 discussed above. FIG. 25 shows the pressuredetecting system 580 in an un-stretched state and FIG. 26 shows thepressure detecting system 580 in a stretched state. Here, the pressuredetecting system 580 also includes a pressure detecting portion 584 thatmay provide information to the health care provider or patient that asufficient tension is reached to apply a desired load through theperianal support member 102 onto the perianal tissue. In thisembodiment, the securing member 582 is an elastically extending memberthat may extend from a neutral or un-stretched condition to a stretchedcondition as discussed above.

The pressure detecting portion 584 in this embodiment comprises areference shape or indicator formed in the elastic strap whose profileprovides an indication of tension loading on the pressure detectingsystem 580. The pressure detecting portion 584 is shown in FIG. 25having a series of non-square rectangular shapes in an un-stretchedstate. This may indicate that the tension loading on the securing member562 is less than a threshold pressure, and therefore, the securingmember 562 is not providing a desired load on the perianal tissuethrough the perianal support member. As the securing member 582 isstretched, the shape of series of non-square rectangular shaped changesto a square shape. This may indicate that a desired tension is in thesecuring member 582 sufficient to apply a desired load on the perianaltissue through the perianal support member 102 when the securing memberis applied in a particular location, such as along the lateral flanks ofthe patient.

The securing member 582 and the pressure detecting portion 584 aredesigned so that the desired pressure on the perianal tissue is achievedwhen the shape of the pressure detecting portion 584 becomes square.Accordingly, when the shape of the pressure detecting portion 584 issubstantially square, the pressure on the perianal tissue has reached orexceeded the desired loading on the perianal tissue. While the shape isshown as square in the embodiment shown, other shapes are contemplatedincluding, for example, any geometric figure, such as circles, stars,and so on. The shapes may be imprinted at intervals or woven orotherwise incorporated into the fabric of the securing member 582.

FIGS. 27 and 28 show another embodiment of an exemplary pressuredetecting system 600 comprising a securing member 602 that may beemployed to secure the perianal support member 102 in place of thesecuring member 106 or 107 discussed above. FIG. 27 shows the pressuredetecting system 600 in an un-stretched state and FIG. 58 shows thepressure detecting system 600 in a stretched state. Here, the pressuredetecting system 600 also includes a pressure detecting portion 604 thatmay provide information to the health care provider or patient that asufficient tension is reached to apply a desired load through theperianal support member 102 onto the perianal tissue. In thisembodiment, the securing member 602 is an elastically extending memberthat may extend from a neutral or un-stretched condition to a stretchedcondition as discussed above, and the pressure detecting portion 602 isone or more strain gauges that measure the strain or extension of thesecuring member 602 in the manner discussed above. In this embodiment,each strain gauge is associated with a wireless transmitter thattransmits the detected information to an off-board interface device 608that may communicate information to the health care provide or thepatient. The off-board interface device 608 and the transmitter may workin a manner similar to those discussed above and may display eitherinformation related to the real-time pressure or may display thresholdinformation indicating whether the pressure is above or below thethreshold.

The pressure detecting portions disclosed herein may enable a healthcare provider of the patient to apply the perianal support device withat least a proper amount of pressure to provide therapeutic support tothe patient during childbirth. Accordingly, the perianal device mayreduce the incidence of a number of complications, including for exampleand without limitation, pelvic floor incompetence or dysfunction, organprolapse, incontinence secondary to pressure and stretching exerted onbladder and bladder neck, over stretching, perineum tears andlacerations, forceps use, and hemorrhoids.

In some embodiments, the perianal support systems describe herein areconfigured to count uterine contractions by monitoring the pressurechanges invoked on the perianal support member 102 by the perianaltissue. That is, during contractions, the perianal support systemsdescribed herein may be configured to detect a change in pressure thatoccurs due to muscle displacement of the perianal tissue. During labor,the contractions of the uterus, along with movement of the baby's headas a result of the uterine muscles, physically displace the perianaltissue. When the perianal tissue is supported by the perianal supportsystems described herein, the result is less perianal tissuedisplacement and an increase in net pressure against the externalpressure surface 104 of the perianal support member 102. These increasesin pressure against the pressure surface 104 can be detected using thepressure detecting systems described above. Accordingly, in addition tomeasuring the pressure statically upon application of the perianalsupport device, the system may be used to monitor dynamic pressure bydetecting changes in pressure at the perianal tissue resulting fromuterine contractions.

Any of the embodiments described herein may also be used to mechanicallyor electrically count uterine contractions by monitoring the changes inpressure that occur during each contraction. An exemplary mechanicalcounter includes for example, a spring loaded plunger that may displacewith displacement of perianal tissue. The plunger may drive a cog orgear to rotate a counting mechanism in a manner similar to hand-heldmechanical counters that count the times a plunger is pressed. Thecounter may display a number disposed for viewing on a numbered wheelindicative of the number of times the plunger presses or the tissuedisplaces. Some embodiments employ the user interfaces described aboveto count each time that the pressure changes by a pre-programmed amount.For example, the pressure detection system may store count each time thepressure increases by a pre-set amount or each time the pressure exceedsa threshold level. In addition to counting the contractions, the systemmay also determine the time between contractions. Depending on theembodiment, this information may be stored and displayed to a user usingany of the interfaces disclosed herein. In some embodiments, thepressure may be shown in real-time as a graph on the user interfacedevices. Pressure peaks may indicate the start of a contraction, and thetime period between peaks may be indicative of the time betweencontractions.

Any of the embodiments described herein may also make up a push meterconfigured to provide an indication of the strength of a push during thebirthing process. For example, by monitoring the changes in pressure onthe perianal tissue by the support member 102 that occur during a push,the pressure detection systems may be able to provide a pressureindication of the strength of a push. In some embodiments, the strengthof the push may be displayed on a user interface in a graph form on auser interface. In other embodiments, the strength of the push may beindicated by the color change, the light bulb activation or otherindicator described herein or that might otherwise indicate the strengthof a push. Accordingly, during the birthing process, the patient and/orthe healthcare provider may observe the systems to determine thestrength of a push.

FIGS. 29 and 30 show yet another embodiment of a perianal supportsystem, referenced by the numeral 650. This embodiment is similar inmany ways to the support system 100 shown and discussed above, and mayinclude any of the features or pressure detecting systems disclosedherein. Like the support system 100, the support system 650 includes theperianal support member 102 having the external pressure surface 104 andthe securing members 106, 107 for attachment to a patient. In addition,the system 650 includes device adjustment elements 652, 654. The deviceadjustment elements 652, 654 extend from the perianal support member 102or the securing members and are configured and arranged to permit thepatient to adjust the support system 650. The adjustment may includemodifying the pressure applied by the support system 650 on the perianaltissue or may include adjusting the physical location of the perianalsupport member 102 on the patient. Accordingly, during contractions orduring pushing, the patient can apply additional pressure on theperianal tissue if desired. Therefore, the patient has some level ofcontrol of the pressure on the perianal tissue.

In this embodiment, the device adjustment elements 652, 654 are strapsthat extend from a location adjacent the perianal support member 102 inthe same direction as the securing members 106, 107. These deviceadjustment elements 652, 654 may be flexible and may be substantiallynon-elastic so that the patient can easily pull the straps toward herhead to increase the relative pressure on the perianal tissue or mayrelease the tension in the straps to reduce the relative pressure on theperianal tissue. In the exemplary embodiment shown, the deviceadjustment elements 652, 654 respectively include a distal end 656, 658and a proximal end 672, 674. The distal end 656 is disposed adjacent toor is connected to the proximal end portion of the compression element116, and the distal end 658 is disposed adjacent to or is connected tothe proximal end portion of the compression element 124.

The proximal ends 672, 674 each include a handle portion 678, 680disposed therein that enable the patient to hold the device adjustmentelements 652, 654. In the example shown, the handle portions 678, 680are through holes in the device adjustment elements 652, 654 that enablea portion of the patient's hand or fingers to extend therethrough. Inother embodiments, the handle portion is formed of a rolled distal endto provide a gripping portion. In yet other embodiments, the handleportion is coated with polyurethane or other friction enhancing materialto allow the patient to comfortably grip the device adjustment elements652, 654 and provide pressure.

The device adjustment elements 652, 654 extend from or adjacent theperianal support member 102 and are shaped and arranged to extend aroundthe patients' flanks. The securing members 106, 107 may secure thesupport system 650 in place when the patient is not providing additionalpressure loading. When additional pressure loading is desired, thepatient may pull the device adjustment elements 652, 654 so that thedevice adjustment elements 652, 654 tighten around the patient's flanksand apply additional loading onto the perianal tissue. In the samemanner discussed above, since the compression elements 116, 124 extendout beyond the crown of the buttocks, additional pulling on the strapsby the patient results in an increase in pressure through the perianalsupport member 102 onto the perianal tissue of the patient. In someembodiments, the patient may monitor any of the pressure detectingsystems described herein, and may adjust the support system using thedevice adjustment elements 652, 654 to maintain the applied pressure ina desired pressure range.

FIG. 31 shows an alternative embodiment of a perianal support system 700using the perianal support member 102, but employing device adjustmentelements that are integrated with the securing members. The supportsystem 700 includes the perianal support member 102 as described abovefor supporting perianal tissue, device adjustment elements 702, 704, andanchor pads 706, 708.

The device adjustment element 702 has a distal end 714 and a proximalend 716. In the embodiment shown, the distal end 714 attaches to andextends from the proximal end portion 120 of the first compressionelement 116. Similar to the device adjustment element 652 describedabove, the device adjustment element 702 is an elongated strap andincludes a handle portion 718 formed therein. The handle portion 718 maybe formed in any manner, as discussed above. In this embodiment, thedevice adjustment element 702 includes a surface (facing away in FIG.31) forming a first half of a fastening system. Here, the surfaceincludes a fastening portion such as a hook and loop system or areleasable adhesive system.

The device adjustment element 704 is similar to the device adjustmentelement 702 and includes a distal end 724 and a proximal end 726. In theembodiment shown, the distal end 724 attaches to and extends from theproximal end portion 128 of the second compression element 124. Similarto the device adjustment element 702, the device adjustment element 704is an elongated strap and includes a handle portion 728 formed therein.The handle portion 728 may be formed in any manner, as discussed above.In this embodiment, the device adjustment element 704 includes a surface(facing away in FIG. 31) forming a first half of a fastening system.Here, the surface includes a fastening portion such as a hook and loopsystem or a releasable adhesive system.

In this exemplary embodiment, the anchor pads 706, 708 are identical andonly the anchor pad 706 will be described, recognizing that thedescription equally applies to the anchor pad 708. The anchor pad 706includes an outer facing side 730 and an inner facing side (not shown inFIG. 31). The outer facing side 730 includes a fastening portion 732configured to fasten to the fastening surface of the adjustment element702. In this embodiment, the fastening portion is one of a hook or loopof a hook and loop fastener. The inner facing side is opposite the outerfacing side 730 and is configured to interface with the patient. In oneembodiment the inner facing side comprises an adhesive configured toadhere the anchor pad 706 to the patient's' skin, as discussed above.The anchor pad 706 also includes a guide 736 disposed thereon. The guide736 is arranged to guide the device adjustment element 702 so that thedistal portion 714 of the device adjustment element 702 is maintained inits lateral position while allowing the distal portion 714 to move in asubstantially axial direction through the guide 736. In this embodiment,the guide 736 is a loop through which the device adjustment element 702extends. However other embodiments include other types of guides.

The device adjustment elements in FIG. 31 allow a patient to quickly andeasily adjust the position of the perianal support member 102 on theperianal tissue and to increase the pressure on the perianal tissue. Inthis embodiment, the patient may adjust the position or the pressureapplied by the perianal support member 102 by manipulating the deviceadjustment elements 702, 704 relative to the anchor pads 706, 708.First, a health care provider may assist the patient by applying theperianal support member 102 in a proper position adjacent the perianaltissue on then patient, and with the device adjustment elements 702, 704respectively fastened to the anchor pads 706, 708. The perianal supportmember 102 may be placed in a first therapeutic static pressure engagingposition having a first pressure. The patient may then adjust theperianal support member 102 to apply a second, even higher pressure toresist contractions by laterally displacing the proximal ends of thedevice adjustment elements 702, 704 so that the inner fastening surfacesdetach from the fastening portion 732 on the outer facing surfaces 730of the anchor pads. With the device adjustment elements 702, 704detached from the fastening portion 732, 734, the device adjustmentelements may be axially displaced through the guides 736 to displace theperianal support member 102 in the lateral directions or to increase ordecrease the pressure applied by the perianal support member 102 on theperianal tissue. When the perianal support member 102 is positioned asdesired at the desired pressure, the patient may manipulate the deviceadjustment elements 702, 704 so that they reattach to the fasteningportion 732 thereby securing the device adjustment elements and theperianal support member 102 in place on the patient. Again, the supportsystem may be manipulated or adjusted as discussed herein to provide adesired pressure on the perianal tissue based on feedback provided bythe pressure detecting systems.

FIG. 32 shows a portion of yet another exemplary embodiment of aperianal support system 750 in accordance with an exemplary aspect ofthe present disclosure. The support system 750 may include the perianalsupport member 102 and the securing members 106, 107 as describedherein. However, FIG. 32 shows an exploded view of a pressure detectingsystem 752 that comprises a pressure sensor 754 and a compliant pad 756.Here, the pressure sensor 754 is disposed between the pressure surface104 and the compliant pad 756.

FIG. 33 shows a portion of yet another exemplary embodiment of aperianal support system 780 in accordance with an exemplary aspect ofthe present disclosure. The support system 780 may include the perianalsupport member 102 and the securing members 106, 107 as describedherein. The support system 780 includes a pressure sensor 782 and acompliant pad 784. In this embodiment however, the pressure sensor 782is disposed within the compliant pad 784. Here, the compliant pad 784comprises a pouch or pocket 786 with an opening formed therein forreceiving the pressure sensor 782. The pressure sensor 782 may beintroduced to the compliant pad 784 in the birthing room or at themanufacturing facility. The pocket 786 may maintain the pressure sensorat the desired location to detect pressure applied against the perianaltissue.

FIG. 34 shows yet another exemplary embodiment of a perianal supportsystem 800 in accordance with an exemplary aspect of the presentdisclosure. The support system 800 may include the perianal supportmember 102 and the securing members 106, 107 as described above withreference to the support system 100 in FIGS. 1-6. In addition, thesupport system 800 includes a pliable receptacle or bag 802 disposedalong the inner surface 132 in the area of the access cavity 136. Insome examples, the pliable receptacle or bag 802 is a cooling applicatorconfigured to receive and maintain a therapeutic cooling material, suchas an ice, a frozen gel, or other ice-pack like material adjacent theperianal tissue. The pliable receptacle or bag 802 is configured to beopened, to receive the cooling material, and to be closed to maintainthe therapeutic cooling material in place adjacent the perianal tissue.In some embodiments, the perianal support member 102 is formed of athermally conductive material that may transfer at least a part of thetemperature of the therapeutic cooling material to the perianal tissueto inhibit swelling and to provide cooling relief. In some embodiments,the pliable receptacle or bag 802 is configured to catch a placenta. Insome embodiments, it is a V-shaped bag that is connectable to theperianal support member 102. In some examples, the perianal supportmember 102 holds an edge of the pliable receptacle or bag 802 tightagainst the patient's body, a position suitable for directly receivingthe placenta as it is expelled from the patient's body.

FIG. 34 shows the pliable receptacle or bag 802 that may form a coolingapplicator 802 for receiving a cooling material or for capturing aplacenta. FIG. 35 shows a perianal support system 810 having a coolingapplicator 808 that comprises a cooling or ice pack formed to nest withthe inner surface 132 in the access cavity 136 of the perianal supportmember 102. Accordingly, the cooling applicator 808 comprises a rigidthermally conductive surface portion 804 shaped to lie flush with atleast an inner portion of the inner surface 132 of the perianal supportmember 102. A container portion 806 may extend from the conductivesurface portion 804 and may be configured and arranged to hold thetherapeutic cooling material. In some embodiments, the container portion806 may be included on the receptacle or bag to form a placenta catcherin the manner discussed above. Accordingly, the placenta catcher may beattached to and may extend from support member 102.

FIG. 36 shows yet another exemplary embodiment of a perianal supportsystem 840 in accordance with an exemplary aspect of the presentdisclosure. This embodiment includes a cooling applicator 842 arrangedto be disposed on the leading end of the perianal support member 102. Inthis embodiment, after the baby is removed from the patient, thehealthcare provider may displace the perianal support member 102 adistance sufficient to place the cooling applicator 842 between theperianal support member 102 and the patient's perianal tissue.Accordingly, the perianal support system is used to support and maintainthe cooling applicator 842 in a position to directly apply therapeuticcooling to the perianal tissue and the surrounding region.

In the embodiment shown, the cooling applicator 842 includes a connectorsupport 844 and a cooling pack 846. The cooling pack 846 is configuredto contain a therapeutic cooling material to provide relief to theperianal and surrounding tissue. The connector support 844 is configuredto attach to or be carried by the perianal support member 102. In theembodiment shown, the connector support 844 is shaped to receive thesurface portion of the perianal support member 102. The shaped connectorsupport may help the perianal support member 102 maintain the coolingapplicator 842 in place. In some embodiments, the cooling applicator 842includes a fastening portion that fastens the cooling applicator 842 tothe perianal support member 102. In some examples, the connector support844 includes an adhesive surface that is configured to adhere to theperianal support member 102. Other examples include a hook and loopfastening strap that extends from the cooling pack to loop around theperianal support member 102 and to secure the cooling applicator inplace. Yet other attachment fasteners are contemplated.

Perianal support devices as described herein may be applied to patientsfor a variety of reasons including, alone or in combination, any of thefollowing: a) shortening second stage labor by providing a push focalpoint to enhance the effectiveness of contractions in advancing the babydown the birth canal, b) reducing the necessity of Cesarean sectionbirths by encouraging and monitoring, via pressure feedback, theeffectiveness of contractions to generate a pushing effect on the babyto move it toward the vaginal opening as sensed by pressure exerted onthe perianal tissue, c) covering all or most of the anal orifice andthereby providing defecation control, d) suppressing hemorrhoiddevelopment and/or advancement of existing hemorrhoids, and e)delivering post-delivery therapeutic treatments, such coolingtreatments, for example.

Returning now to FIGS. 1 and 2, in use a health care provider positionsthe patient 10 to expose the perianal region 26. In the child birthingprocess, the patient 10 may be positioned in stirrups attached to adelivery table (not shown). The perianal support system 100 is thenmoved adjacent the gluteal cleft 13 between buttocks 14 and 15. Thesupport system 100 is positioned such that the midline 108 of theperianal support member 102 is substantially aligned with the patient'smidline within the sagittal plane. Referring to FIG. 1, the perianalsupport member 102 is advanced in the direction of arrow A1 toward theanal orifice 38 (generally within the sagittal plane toward the head ofthe patient) to bring the pressure surface 104 into contact with theperianal tissues. Continued advancement of the perianal support member102 toward the anal orifice 38 applies pressure through the pressuresurface 104 to the perianal tissues. In one aspect, the healthcareprovider places at least one finger within the access cavity 136 andpreferably against internal contact surface 170 to advance the deviceagainst the anal orifice 38. The healthcare provider utilizes a pressurefeedback device associated with the perianal support device to sensethat the initial placement exceeds a first pressure threshold. In oneexemplary embodiment, the first pressure threshold is within a pressurerange of about 0-770 mm of mercury. In one aspect, the initialpositioning of the support device is spaced from or only in touchingengagement without creating pressure when the patient is notexperiencing a contraction. As a contraction occurs or the patientpushes, the perianal tissues will tend to protrude thereby engaging thedevice with a pressure that can be felt by the mother through tactilefeedback and sensed by the pressure detection system. In still a furtheraspect, the pressure thresholds needed for adequate tactile sensationvary between patients such that the first pressure threshold may be in arange from 40-120 mm of mercury. In a further form, the second pressurethreshold needed to enhance tactile sensation need only to be higherthan the first pressure. In one aspect, the second pressure thresholdcan be in the range of 80-250 mm of mercury. With continued pressureapplied by the healthcare provider to the access cavity 136, and/orinternal contact surface 170, the elongate securing member 107 extendslaterally of the anal orifice 38 away from the gluteal cleft 13 and isreleasably attached to the patient 10 to at least the lateral flank 18.In a similar manner, with compressive force applied by the healthcareprovider the perianal support member 102, the elongate securing member107 extended laterally of the anal orifice 38 out of the gluteal cleft13 and is secured to the patient adjacent lateral flank 19 to maintainthe device on the patient in the static pressure therapeutic zoneexceeding the first threshold. Thus, the securing members 106, 107 ofthe system 100 do not extend along the patient midline in the glutealcleft 13 with the potential for interference with the birthing process,but instead extend substantially laterally from the patient's midlineout of the gluteal cleft 13 and are attached at the patient's lateralflanks 18 and 19.

The extent of tissue deformation surrounding the anal orifice 38 whensupport system 100 is applied is a function of the patient anatomy andof the amount of compressive force applied during application of thesupport system 100. As shown in FIG. 1, the maximum extent of perianaltissue engagement inwardly on the patient in the saggital plane is shownby line 178. In one aspect, it is contemplated that pressure applied inthe direction of arrow A1 moves the anal orifice inwardly 1 cm to 3 cm.In one embodiment, the lateral ends 144, 146 of the securing members106, 107 extend beyond line 178 generally in the patient's saggitalplane. The securing members 106, 107 exert tension forces generally inthe direction of arrows A2 and A3, respectively. This tension force isapplied to compression elements 116, 124, which are substantially rigidmembers capable of transmitting compressive forces to the perianalsupport member 102. The tension force applied on the lateral flanks 18and 19 of the patient 10 in the direction of arrows A2 and A3 isconverted to compressive forces in the direction of arrows A4 and A5,respectively. The compressive forces A4 and A5 are transmitted bysubstantially rigid compression elements 116, 124 and ultimately to thepressure surface 104 to apply support and/or pressure to the perianaltissues in the direction of arrow A1. It will be appreciated that thelateral components of compressive forces applied in A4 and A5 helps tomaintain the position of the perianal support member 102 as well astending to maintain access cavity 136 in an open position.

Still referring to FIGS. 1 and 2, each compression element 116, 124 hasa length L1 and extends away from each other by an angle A1. The maximumlateral distance of the access cavity is defined by the distance D1extending between distal end portions 120, 126. In one embodiment, L1 isgreater than 4 cm in length. In a preferred aspect, L1 is approximately8 cm. In one embodiment angle A1, is between 140 degrees and 30 degrees.In the illustrated embodiment, angle A1 is approximately 80 degrees. Inone embodiment, the maximum lateral distance D1 of the access cavity 136is greater than 4 cm. In the illustrated embodiment of FIG. 1, themaximum lateral distance is approximately 10 cm. It will be understoodthat while compression elements 116, 124 are sufficiently rigid totransmit compressive force toward the pressure surface, in oneembodiment they are flexible, at least laterally, to bow or bend inresponse to force applied to the securing members 106, 107. In contrast,the anterior to posterior distance of the pressure surface 104 betweenthe first edge 110 and second edge 112 is approximately 5 cm in theillustrated embodiment. This midline length between the first edge 110and the second edge 112 of the perianal support member 102 can beadjusted in some embodiments depending on the amount and extent ofperianal tissue that needs to be supported.

The distance D2 between the anal orifice and the buttocks crown 16 isless than the distance D3 between the distal end 64 of the flange 60 andthe anal orifice. Thus, tension applied to securing members 106, 107 istransferred through substantially rigid compression elements 116, 124,to exert a compressive force on pressure surface 30 in the direction ofarrow A1. Whereas, if distance D2 is greater than distance D3 tensionapplied to securing members 106, 107 may pull the perianal supportmember 102 in a direction opposite arrow A1.

It will be appreciated that with the illustrated embodiment, thehealthcare provider may reposition the perianal support member 102 andadjust the compressive force applied through the securing members 106,107 to the pressure surface 104 by releasing or adjusting the attachmentbetween the securing members 106, 107 and the patient 10.

Additionally, in the illustrated embodiments, the perianal supportmember of the support systems is sized and positioned with respect topatient 10 to allow for the passage of a child through the birthingcanal during childbirth. It is contemplated that the perianal supportmember may be placed to support more or less of the perineum between theanus and vaginal opening depending on the health care provider'sjudgment and the progress of the child birthing process. Still further,it is contemplated that an elongated anterior to posterior device may bepositioned to support at least a portion of the perianal tissue and thevaginal tissue during the labor process. It is anticipated that thesupporting device will be repositioned posteriorly away from the vaginalopening prior to delivery of the child through the vaginal opening.

In use, a health care provider positions the patient to expose theperianal region and vagina. Referring now to FIG. 37, there is a shown aflow chart illustrating a method of utilizing a labor management deviceaccording to one aspect of the present disclosure to manage a mother'slabor process to reduce the duration of second stage labor and increasethe incidence of a vaginal delivery without increasing tissue damage tothe mother. In general terms, the method includes applying a tactilefeedback device in engagement with the perianal tissue and monitoringthe progression of labor during the second stage. With respect to FIG.37, the method begins at step 900 by determining whether the expectingmother has previously delivered a child by a vaginal delivery. If theanswer to this inquiry is yes, then at step 902, the progress of laboris monitored to determine if labor is progressing as desired at step904. In one instance, the progression of labor can include the amount ofmovement of the child toward the vaginal opening over a given a periodof time. In another instance, the progression of labor can includeshortening or thinning of the cervix, the amount of cervical dilation,digital (finger) assessment of fetal position, assessment of fetaldecent, the amount of movement of the child toward the vaginal openingin comparison to the number of contractions or successful pushes themother has experienced. The determination of the progression of labormay be made by a healthcare provider monitoring the patient or by anelectronic monitoring system receiving one or more inputs indicative oflabor progression such as the number of contractions, effective pushes,and movement of the child within the mother and/or overall time oflabor. As long as labor is progressing as desired, the method continueswith monitoring the progress of labor. If labor is not progressing asdesired in step 904, then the method progresses to the application of atactile feedback device (TFD) in a first tactile position at step 906which could include devices similar to any of the device embodimentsdescribed above or any other device configured and applied to provideperianal tactile sensation to the patient. A first tactile position caninclude applying a TFD in a pressure inducing and tissue compressionengagement at a first pressure threshold, engagement with the perianaltissue without pressure inducement or tissue compression, or positioningadjacent the perianal tissue sufficiently close such that during a pushby the mother, the protrusion of soft perianal tissue will engage theTFD to provide a tactile sensation to the mother. Once the TFD ispositioned in the desired first tactile position, the method includesthe step at 912 of securing the TFD to the mother in the first position.

During initialization of the method in step 900, if it is determinedthat the mother has not previously had a successful vaginal delivery orhas previously undergone a Cesarean section child delivery procedure,the method continues to step 910 where a TFD is applied in a firsttactile position to provide perianal tactile sensation to the mother. Ofcourse, use of the methods and devices described above can be applied toall patients; however, it may be desirable in some situations to limituse of the labor management devices and techniques to those patientsmostly likely to benefit from the added attention and treatment. Asdescribed above, a first tactile position can include applying a TFD ina pressure inducing and tissue compression engagement at a firstpressure threshold, engagement with the perianal tissue without pressureinducement or tissue compression, or positioning adjacent, but spacedfrom, the perianal tissue in a sufficiently close arrangement such thatduring a push by the mother, the protrusion of soft perianal tissue willengage the TFD to provide a tactile sensation to the mother. Once theTFD is positioned in the desired first tactile position, the methodincludes the step at 912 of securing the TFD to the mother in the firstposition in any suitable manner, including the secure techniquesdisclosed herein.

After the TFD is positioned, the method of using a TFD to manage amother's labor continues at step 914 by monitoring the progress oflabor. In one instance, the progression of labor can include shorteningor thinning of the cervix, the amount of cervical dilation, the amountof movement of the child toward the vaginal opening over a given aperiod of time. In another instance, the progression of labor caninclude the amount of movement of the child toward the vaginal openingin comparison to the number of contractions or successful pushes themother has experienced. As mentioned above, the TFD may include acounting component to track the number of successful pushing episodesexperienced by the device. The determination of the progression of labormay be made by a healthcare provider monitoring the patient or by anelectronic monitoring system receiving one or more inputs indicative oflabor progression such as the number of contractions, effective pushes,and movement of the child within the mother and/or overall time oflabor. As long as labor is progressing as desired in step 916, themethod continues with monitoring the progress of labor in step 914. Iflabor is not progressing as desired in step 916, then the methodprogresses to modifying the position of the TFD at step 918 to move theTFD to a second tactile position on the mother to thereby increase thetactile sensation for the mother. Similarly, the monitoring of the laborprocess also takes into account the administration of sensory numbingmedications administered to the mother at step 920. As will beappreciated, the application of numbing medications, including spinalepidurals, orally administered pain relievers and intravenously injectedpain relievers, may significantly reduce the mother's ability to feelpain along with tactile sensation in the perianal tissues. As a result,the method of managing the labor process advances to step 918 toincrease the amount of tactile sensation applied to the perianaltissues.

In one aspect, in order to increase tactile sensation at step 918, theTFD is moved to a second tissue engaging position where the amount ofpressure applied to the perianal tissue is increased compared to thefirst tactile position. In an exemplary embodiment, the TFD includes apressure indication mechanism that provides feedback to the individualmoving the device about how pressure is being applied, or if thepressure is increasing from the first position, as the TFD is moved tothe second position against the perianal tissues. In an alternativeform, the healthcare provider applies inward (toward the anus) movementof the TFD while receiving feedback from the mother concerning herability to sense the increased tactile sensation. Once the motherindicates a desired level of tactile sensation, the healthcare provider(or the patient in patient manipulated embodiments) secures the devicein the second position at step 922. As will be appreciated, the processof monitoring labor in step 914 and increasing the tactile sensation (ormanaging the labor process to decrease the tactile sensation if themother experiences excessive pain) can be repeated multiple timesthroughout the labor process to manage a balance between causingpain/injury to the mother and provides the mother with a tactilesensation to push against to generate more effective pushes withincreased movement of the child into and through the birth canal. Morespecifically, at step 930, tissue adjacent the TFD is monitored to avoidapplying too high a pressure on the tissue for too long of a timeperiod. Thus, in step 932 if it is determined that the current positionof the TFD may cause tissue injury, then in step 934 the TFD device canbe moved to reduce the pressure on the perianal tissue. In oneembodiment, the TFD includes a mechanism for alerting the user to anover pressure situation and this mechanism can provide feedback on theforce exerted on the perianal tissue.

The above described labor management method may be implemented in avariety of child birthing processes, however in a typical child birthingprocess, the patient may be positioned in stirrups attached to adelivery table. If used, anchor pads 182, 188 are adhered to thepatient's skin on the lateral flanks 18 and 19, respectively. As bestseen in FIG. 2, the anchor pads 182, 188 are positioned on the lateralflanks 18 and 19 laterally adjacent the junction of the femur with thepelvis. The perianal support device 100 is then moved adjacent thegluteal cleft 13 between buttocks 14 and 15. The midline 48 of thesupport device is generally aligned with the patient midline within thesagittal plane. The support device is advanced in the direction of arrowA1 toward the anal orifice 38 (generally within the sagittal plane) tobring the perianal support member 102 into contact with the perianaltissues. Continued advancement of the support device toward the analcanal applies pressure through the pressure surface 104 to the perianaltissues. In one aspect, the healthcare provider places at least onefinger within the access cavity 136 and preferably against internalcontact surface 170 to advance the device against the anal orifice. Inanother aspect, an instrument having complimentary engagement surface toat least a portion of the access cavity 136 is used to apply pressure tothe device 100. The healthcare provider may then observe the pressuredetecting system as disclosed herein to determine whether a suitablepressure is being applied to the device. If more pressure is desired asindicated by the pressure detecting system, then the healthcare providermay provide additional pressure.

With continued pressure applied by the healthcare provider to the accesscavity 136, and/or internal contact surface 170, elongated securingmember 106 is extended laterally of the anal orifice 38 out of thegluteal cleft 13 and releasably attached to anchor pad 182 with at leastlateral end 144 extending adjacent lateral flank 19. In a similarmanner, with compressive force still applied by the healthcare providerto support device 100, elongate securing member 107 is extendedlaterally of the anal orifice 38 out of the gluteal cleft 13 and issecured to anchor pad 588 with at least lateral end 146 extendingadjacent lateral flank 18. In embodiments employing pressure detectingsystems in the securing members to determine whether a suitable pressureis being applied to the device, the healthcare provider may visuallyobserve the securing members or may be able to identify by tactilefeedback when a suitable pressure is applied by the support system 100.If more pressure is desired as indicated by the pressure detectingsystems, then the healthcare provider may provide additional pressure.The fixation members 106, 107 of the system 100 do not extend along thegluteal cleft 13 with the potential for interference with the birthingprocess but instead extend substantially laterally from the patient'smidline out of the gluteal cleft 13. In embodiments having deviceadjustment elements that may be manipulated by the patient, the patientmay adjust the pressure applied by the system based on feedback from thepressure detecting systems.

The extent of tissue deformation surrounding the anal orifice 38 is afunction of the patient anatomy and of the amount of compressive forceapplied during application of the support device 100. In one aspect, thehealth care provider makes initial contact with anal orifice 38 and thenapplies pressure in the saggital plane (generally toward the patient'shead) to advance the device 1 cm to 3 cm. This advancement of the deviceapproximately 1 cm to 3 cm compresses the perianal tissue and therebysupports the tissue to inhibit distention as the patient pushes duringthe birthing process. It will be appreciated that with the illustratedembodiment, the healthcare provider may reposition the device and adjustthe compressive force applied through the compression members 106, 107to the pressure surface 104 by releasing or adjusting the attachmentbetween the anchor pads 182, 188 and the fixation members 106, 107.

In an alternative approach, the pressure surface 104 is positioned inengagement with the anal orifice with little if any compressive forceapplied to deform the perianal tissue. The support device is thensecured in position as described above. With this technique, the supportdevice will resist movement of the device in a direction generally awayfrom the patient's head and will thereby support the perianal tissue tomaintain its position. In a further feature, a pressure feedback devicemay indicate outward pressure on the perianal tissue to provide feedbackto the patient on successful pushing during contractions.

Still referring to FIG. 1, with system 100 in position, a healthcareprovider is allowed to position one or both hands within the accesscavity 136 extending into the gluteal cleft. In this manner, the handsmay be below the lowest portion of the vaginal opening 11 as the head ofthe baby 12 passes out of the vagina. Thus, the hand within the accesscavity 136 is positionable less than 1 cm from the mother's vaginalopening or perineum so the healthcare provider may support the head ofthe baby as is it is being born. The position of second edge of thesupport device 100 also allows access to the tissue immediately belowthe vaginal opening 11 in the event an obstetric maneuver, such as anepisiotomy, manipulation of the fetus, etc., is necessary. Further, asdiscussed above, in one aspect the perianal support member 102 isquickly repositioned or removed by releasing at least one of the strapsfrom the anchor pads, an obstetric maneuver is performed, the perianalsupport member 102 is repositioned in a supporting position adjacent theanus and the anchoring straps are repositioned on the anchor pads.Therapeutic cooling may be applied by attaching or securing a coolingapplicator in place using the system 100.

In one embodiment, the support system is formed of biocompatiblematerial suitable for contact with human tissue. Moreover, in oneembodiment, the device is provided sterile in a package for single useapplication on a patient, although reusable devices according to thepresent teachings are also disclosed in the present description. In thesingle use type of embodiment, the device is cost effectivelymanufactured such that it is discarded after use. For example, thedevice 100 is formed by of a substantially rigid polycarbonate material.In one aspect, the device 100 is injection molded to substantially itsfinal V-shaped form. The compliant pad is then applied to the apex andsecuring members are joined to the compression members via an adhesive.It is contemplated that securing members 106, 107 may be riveted,snapped or otherwise fixedly attached to the compression elements. Stillfurther, in a different embodiment, the securing members are passedthrough a channel or other opening associated with the compressionelements to loosely and/or removably join the securing member to theperianal support member 102. In one aspect, compression elementscomprise a loop portion of a hook and loop fastening system, such assold under the tradename VELCRO.

It is contemplated that in other embodiments, the perianal supportmember 102 is formed by compression molding, transfer molding, reactiveinjection molding, extrusion, blow molding, casting, heat-forming,machining, deforming a sheet, bonding, joining or combinations thereof.In other embodiments, suitable materials for device 300 includepolymers, metals, ceramics or combinations thereof. The materials can beor include alone or in combination: hard solids, soft solids, tackysolids, viscous fluid, porous material, woven fabric, braidedconstructions, or non-woven mesh. Examples of polymers includepolyethylene, polyester, Nylon, Teflon, polyproplylene, polycarbonate,acrylic, PVC, styrene, PEEK, etc. Examples of ceramics include alumina,zirconia, carbon, carbon fibers, graphites, etc. Examples of suitablemetals include titanium, stainless steel, cobalt-chrome, etc.

It is contemplated that in still further embodiments, the complaint padcan be made from or includes at least one of the following, either aloneor in combination: woven fabric, non-woven mesh, foam, film, poroussheet, and non-porous sheet. At least the perianal support member 102and compliant pad are sterilized by known techniques; such as ethyleneoxide gas, gas plasma, electron-beam radiation or gamma radiation. Suchmaterials are available from various suppliers such as 3M. In a similarmanner, the fixation members or straps may be formed of hook and loopfastening systems available from 3M. Adhesive fixation systems may beadhesive a Rayon woven tape on a liner (1538L from 3M). The tape mayinclude liners to prevent premature tape adhesion. In one embodiment,the liners include a cut between the midline end adjacent device 300 andthe lateral end. During initial placement, the device is pushed againstthe anus with a first hand. The opposite hand spreads the buttocks awayfrom the device while the first hand pushes the perianal support memberto get further compressive penetration in the gluteal cleft. The handsare switched and the steps are repeated on the opposite buttocks. Afterposition the device, the liners adjacent the device are sequentiallyremoved and adhered to the medial portion of the buttocks forprovisional positioning of the device. Once the device is provisionallypositioned, the first lateral liner is removed and with pressure appliedto the device, the lateral tape segment is adhered to the patient in afinal supporting position to supply compressive force to the device.This step is repeated on the opposite side for final fixation.

The present invention also contemplates a kit that includes one or moreof the components described above provided in a package. In oneembodiment, the kit includes at least a sterilized perianal supportdevice. In another aspect, the kit further includes an anchoringassembly as described above. In another aspect, the kit includes apressure detecting system. In another aspect, the kit includes a patientadjustment system. In some embodiments, the anchoring assembly may bepreassembled with the perianal support device as shown in the drawingsor may be provided unassembled. In the unassembled kit, a health careprovider will remove the support device and anchoring assembly from thepackaging and assembly the support device with the anchoring assemblyand the pressure detecting system. As set forth above, the anchoringassembly may be adhered to the support assembly near the patient or thesupport assembly may include fastening members or apertures to receiveelements of the anchoring assembly. For example, the support device mayinclude an aperture and a portion of a flexible strap may be threadedthrough the aperture to join the two components. In still a furtherembodiment, the kit includes a treating compound to apply to thepatient. In one such embodiment, the treating compound is provided in aseparate package. In an alternative embodiment, the treating compound isapplied to or incorporated into the support device on the perianalcontact surface.

The foregoing outlines features of several embodiments so that thoseskilled in the art may better understand the aspects of the presentdisclosure. Those skilled in the art should appreciate that they mayreadily use the present disclosure as a basis for designing or modifyingother processes and structures for carrying out the same purposes and/orachieving the same advantages of the embodiments introduced herein.Those skilled in the art should also realize that such equivalentconstructions do not depart from the spirit and scope of the presentdisclosure, and that they may make various changes, substitutions andalterations herein without departing from the spirit and scope of thepresent disclosure. Furthermore, although elements of the describedembodiments may be described or claimed in the singular, the plural iscontemplated unless limitation to the singular is explicitly stated.Additionally, all or a portion of any aspect and/or embodiment may beutilized with all or a portion of any other aspect and/or embodiment.

What is claimed is:
 1. A child birth labor pelvic floor supportapparatus, comprising: a support member comprising: a pressure surfaceconfigured to apply pressure on tissue adjacent a pelvic floor of apatient to support the pelvic floor during child birth; a compressionelement extending in a direction from the pressure surface andconfigured to convey applied loading toward the pressure surface tomaintain the pressure surface in a position that applies the pressure onthe tissue to support the pelvic floor; and a pressure detecting systemconfigured to detect pressure on the tissue adjacent the pelvic floor ofthe patient.
 2. The childbirth labor pelvic floor support apparatus ofclaim 1, wherein the pressure detecting system comprises: a pressuredetecting element configured to detect pressure applied on the tissueadjacent the pelvic floor by the pressure surface; and a user interfaceconfigured to display information relating to the pressure detected bythe pressure detecting element.
 3. The childbirth labor pelvic floorsupport apparatus of claim 2, wherein the user interface is configuredto wirelessly communicate with the pressure detecting element.
 4. Thechildbirth labor pelvic floor support apparatus of claim 1, wherein thepressure detecting system comprises a compliant pad on a pressuresurface of the childbirth labor pelvic floor support apparatus and thecompliant pad is configured to change appearance when the pressureexceeds a threshold pressure.
 5. The childbirth labor pelvic floorsupport apparatus of claim 1, wherein the tissue adjacent the pelvicfloor includes at least a portion of a perineum between an anus and avaginal opening of the patient.
 6. The childbirth labor pelvic floorsupport apparatus of claim 1, wherein the pressure detecting systemcomprises: a securing member extending from the childbirth labor pelvicfloor support apparatus, the securing member being configured to conveyinformation indicative of the pressure applied on the tissue adjacentthe pelvic floor adjacent an anal orifice of the patient by the pressuresurface.
 7. The childbirth labor pelvic floor support apparatus of claim6, wherein the securing member comprises an element configured to changeappearance when pressure changes.
 8. The childbirth labor pelvic floorsupport apparatus of claim 1, further comprising a counter associatedwith the pressure detecting system, the counter configured to countpressure sequences above a first threshold indicative of effectivepushes of the patient during child birth labor.
 9. The childbirth laborpelvic floor support apparatus of claim 1, wherein the compressionelement comprises: a first rigid compression element surface disposed toface a first buttock in a gluteal cleft of the patient in response tothe pressure surface being disposed adjacent an anal orifice of thepatient, the first compression element surface extending away from thepressure surface in a first direction out of the gluteal cleft; and asecond rigid compression element surface disposed to face a secondbuttock in the gluteal cleft of the patient in response to the pressuresurface being disposed adjacent the anal orifice, the second compressionelement surface extending away from the pressure surface in a seconddirection out of the gluteal cleft.
 10. A child birth labor managementapparatus, comprising: a tissue engagement portion configured to applypressure on tissue adjacent a pelvic floor of a mother in child birthlabor; a load transfer portion configured to convey an applied load tothe tissue engagement portion; and a user interface configured topresent information relating to a pressure level applied by the tissueengagement portion on the tissue adjacent the pelvic floor of the motheras a result of the applied load.
 11. The child birth labor managementapparatus of claim 10, wherein the load transfer portion comprises:first and second surfaces formed of one or more rigid compressionelements extending away from the tissue engagement portion in adirection out of a gluteal cleft of the mother.
 12. The child birthlabor management apparatus of claim 10, wherein the user interfacecomprises: a securing member attached to and extending from the childbirth labor management apparatus, the securing member being configuredto convey information indicative of pressure applied on the tissueadjacent the pelvic floor of the mother by the tissue engagementportion.
 13. The child birth labor management apparatus of claim 12,wherein the securing member comprises an elastic strap arranged tostretch and generate the applied load on the load transfer portion. 14.The child birth labor management apparatus of claim 10, wherein the userinterface comprises a display screen configured to present informationto a user indicating pressure on the tissue adjacent the pelvic floor ofthe mother.
 15. The child birth labor management apparatus of claim 10,wherein the user interface comprises: a load detecting element connectedto the child birth labor management apparatus and configured to detect aload indicative of pressure applied by the tissue engagement portion onthe tissue adjacent the pelvic floor of the mother; and a displayelement associated with the load detecting element to convey thedetected load to the user.
 16. The child birth labor managementapparatus of claim 15, wherein the load detecting element comprises apressure sensor.
 17. The child birth labor management apparatus of claim15, wherein the load detecting element comprises a pressure responsivepad and the display element comprises a portion of the pad that isconfigured to change color when a pressure threshold is exceeded. 18.The child birth labor management apparatus of claim 15, wherein the loaddetecting element comprises a strain gauge.
 19. The child birth labormanagement apparatus of claim 10, wherein the user interface comprises apressure switch configured to complete an electrical circuit when thepressure level applied by the tissue engagement portion on the tissueadjacent the pelvic floor of the mother is above a threshold level. 20.A pelvic floor support device, comprising: an external pressure portionconfigured to engage tissue adjacent the pelvic floor of a patientduring child birth labor; a compression element configured to provide aload to the external pressure portion to maintain the external pressureportion engaged with the tissue with a pressure amount; and a pressuredetection system configured to detect the pressure amount.
 21. Thepelvic floor support device of claim 20, wherein the compression elementcomprises: a first compression element extending at a first angle fromthe external pressure portion in a first direction; and a secondcompression element extending at a second angle from the externalpressure portion in a second direction, the first and second anglesbeing approximately equal and the first and second directions beingdifferent from each other.
 22. The pelvic floor support device of claim20, wherein the pressure detection system comprises: a pressuredetection pad coupled to the external pressure portion such that thepressure detection pad rests between the tissue and the externalpressure portion, the pressure detection pad comprising an internalcushioning structure.
 23. The pelvic floor support device of claim 22,wherein the pressure detection pad comprises: a friction surface thatcomes in contact with the tissue; and a treating compound disposed withthe pressure detection pad.
 24. The pelvic floor support device of claim20, wherein the pressure detection system is configured to dynamicallydisplay a color indicative of the pressure amount, wherein differentcolors are associated with different therapeutic pressure levels. 25.The pelvic floor support device of claim 20, further comprising: acooling pack comprising a therapeutic cooling material, the cooling packbeing configured to attach to a surface of the external pressure portionand come in contact with the tissue adjacent the pelvic floor to providerelief to the contacted tissue.
 26. A pelvic floor support device,comprising: a pressure surface configured to engage tissue adjacent thepelvic floor of a patient during child birth labor; a compressionelement configured to provide a load to the external pressure surface tomaintain the external pressure surface engaged with the tissue with apressure amount; and a pressure sensor configured to detect the pressureamount.
 27. The pelvic floor support device of claim 26, furthercomprising: a transmitter disposed beneath a surface of the pressuresurface, the transmitter being in communication with the pressure sensorand configured to: receive, from the pressure sensor, a signalindicative of the pressure amount detected by the pressure sensor; andtransmit the received signal to a separate receiver that is remote fromthe transmitter and configured to display information based on thereceived signal to a user.
 28. The pelvic floor support device of claim27, wherein the separate receiver comprises a mobile communicationdevice associated with the user.
 29. The pelvic floor support device ofclaim 26, wherein the pressure sensor comprises: a strain gauge coupledto the compression element and configured to detect strain in thecompression element during the child birth labor; and a transmitterconfigured to transmit the detected strain representative of thepressure amount to a user interface.
 30. The pelvic floor support deviceof claim 26, further comprising: a light in communication with thepressure sensor, wherein the light is configured to: output a firstcolor in response to the pressure amount exceeding a first thresholdlevel; output a second color in response to the pressure amountexceeding a second threshold level; and output a third color in responseto the pressure amount exceeding a third threshold level, wherein thesecond threshold level is greater than the first threshold level and thethird threshold level is greater than the second threshold level.